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Procedures
Area of Interest
Head
Midface Fractures
MODUS 2 Midface
MODUS 2 IMF
MODUS 0.9/1.2
Mandibular Fractures
MODUS 2 MANDIBLE
MODUS 2 IMF
MODUS TBS
Mandibular Reconstruction
MODUS 2 MANDIBLE
Orthognathic Surgery
MODUS 2 ORTHOGNATHICS
MODUS 2 IMF
Occlusion
MODUS 2 IMF
Tooth stabilization
MODUS TTS
Alveolar ridge augmentation
MODUS BFS
Hand
Metacarpal /Phalangeal fracture osteosynthesis
APTUS Hand System 1.2 - 2.3
CCS
Metacarpal /phalangeal osteotomy
APTUS Hand System 1.2 - 2.3
CCS
Carpal arthrodesis
APTUS Hand System 1.2 - 2.3
CCS
CMC-I Fusion System
Scaphoid non-union
APTUS Hand System 1.2 - 2.3
Wrist arthrodesis
APTUS Arthrodesis 2.5
Joint replacement
Touch Prothesis
Keriflex
Soft tissue repair
KeriFix KeriLock
Wrist
Distal radius fracture osteosynthesis
Distal Radius and Distal Ulna System 2.5
CCS
Distal ulna fracture osteosynthesis
Distal Radius and Distal Ulna System 2.5
CCS
Correction osteotomy
Distal Radius and Distal Ulna System 2.5
CMX Wrist
Wrist arthrodesis
APTUS Arthrodesis 2.5
Ulnar shortening osteotomy
Ulna Shortening System 2.5
CMX Wrist
Forearm
Fractures of the bones of the forearm
Radius & Ulna Shaft 2.8
CCS
Osteotomies of the bones of the forearm
Radius & Ulna Shaft 2.8
CMX Forearm
Elbow
Radial head fractures
Radial Head 2.0
Olecranon fracture/osteotomy
Olecranon Plates 2.8
Coronoid Fractures
Coronoid Plates 2.0
Distal Humerus Fractures
Distal Humerus Plates 2.8
Shoulder
Proximal Humerus Fractures
Proximal Humerus System 3.5
CCS
Clavicle Fractures
Clavicle System 2.8
CCS
Foot & Ankle
Forefoot
Hallux Valgus / Varus
Hallux System 2.8
All in One Staple
Fore and Midfoot System 2.0 / 2.3 / 2.8
CCS
Hallux Rigidus / Hallux Limitus
Hallux System 2.8
Fore and Midfoot System 2.0 / 2.3 / 2.8
CCS
Bunionette
Fore and Midfoot System 2.0 / 2.3 / 2.8
Hammer Toe & Claw Toe
SpeedTip C System
Metatarsal Fractures
Fore and Midfoot System 2.0 / 2.3 / 2.8
Midfoot
Lisfranc Dislocation
Fore and Midfoot System 2.0 / 2.3 / 2.8
Midfoot Fractures
Fore and Midfoot System 2.0 / 2.3 / 2.8
Hindfoot
Pes Cavus
Fusion System
Mid- and Hindfoot System
Pes Planus
Fusion System
Mid- and Hindfoot System
Ankle Arthritis
Ankle Trauma System
Calcaneal Fracture
Calcaneus System
Ankle
Fibula osteosynthesis
Ankle Trauma System
Tibia osteosynthesis
Ankle Trauma System
Supramalleolar osteotomy
Ankle Trauma System
Solutions
Upper Extremities
Hand
Hand 1.2–2.3
CMC-I Fusion System 2.0, 3.0
Arthrodesis System 2.0/2.3, 2.5
CCS Upper Extremities
TOUCH
®
KERIFLEX
®
KERIFIX
®
KERIFUSE
®
Wrist
Distal Radius and Distal Ulna System 2.5
Arthrodesis System 2.0/2.3, 2.5
Ulna Shortening System 2.5
CCS Upper Extremities
CMX Upper Extremities
Forearm
Radius Ulna Shaft System 2.8
CMX Upper Extremities
CCS Upper Extremities
Elbow
Radial Head System 2.0
Olecranon System 2.8
Distal Humerus System 2.8
Coronoid Plates 2.0
CCS Upper Extremities
Shoulder
Clavicle System 2.8
Proximal Humerus System 3.5
CCS Upper Extremities
CCS Upper Extremities
Lower Extremities
Foot
All-in-One Staple
Fore- and Midfoot System 2.0/2.3, 2.8
Mid- and Hindfoot System 2.8, 3.5
SpeedTip C System 2.0, 2.8
Hallux System 2.8
Fusion System 3.5
Calcaneus System 3.5
Ankle
Ankle Trauma System 2.8/3.5
CCS Lower Extremities
CCS Lower Extremities
CMF
Midface
MODUS 2 Midface
MODUS 2 IMF
MODUS BFS 0.9/1.2, 1.5
MODUS 0.9/1.2
MODUS TTS
Mandible
MODUS 2 Mandible
MODUS 2 IMF
CMX CMF
MODUS 2 WSD
MODUS 2 TBS
MODUS CFS 1.8
Orthognathics
MODUS 2 Orthognathics
MODUS 2 IMF
CMX CMF
MODUS 2 WSD
MODUS 2 TBS
APTUS SpeedTip CCS
CCS Upper Extremities
CCS Lower Extremities
CMX — Personalized Services
CMX Indications
CMX Upper Extremities
CMX Lower Extremities
CMX CMF
CMX Services
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QMS Form
Recording Data
Customer Data
Product Data
Complaint Information
Patient Impact and Data
Recording Data
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*
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Date of Awareness
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Customer Data
Clinic/Hospital
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City, State
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Surgeon Name
First Name
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Last Name
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Report requested by surgeon?
Yes
Product Data
Product Line
*
Please Select
Medartis APTUS
Medartis MODUS
Medartis CMX
Keri Medical
Field Orthopedics
LapiPrep
Lapidus Cut Guide
Komet
Kellmed
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Article Number
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Article Name/Description
*
Lot Number
*
Quantity
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Distribution type
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Direct Sales
Loan Set
Consignment Set
Equipment/Set Number
*
Complaint Information
When did the incident occur?
*
Pre-operative
Intra-operative
Post-operative
During Explantation
Date of Incident/Failure Detection
*
Date of Surgery
Delay of Surgery
*
Description of defect/complaint
*
How was the problem solved by the surgeon?
*
Upload photo (e.g. from reported issue)
Scope of indication
Will the Product be returned?
*
Yes
No
Why is the product unavailable?
Why is the product unavailable?
*
Note:
Product can only be returned in a cleaned condition + proof of cleaning.
Patient Impact and Data
Impact
*
SPHT: Death or permanent serious deterioration of health (e.g. remaining paralysis, remaining injury, irreparable injury of nerves) which lead or may lead to a Serious Public Health Threat
(5) Critical: Death - Permanent serious deterioration of health (e.g. remaining paralysis, remaining injury, irreparable injury of nerves)
(4) Major: Temporary deterioration of health (e.g. infection, inflammation, allergies)- extended anaesthesia during the surgery (≥ 60 min) - Second surgery necessary- Reparable injury to blood vessels - Soft tissue irritation and/or nerve damage through surgical trauma, double vision
(3) Moderate: Extended anaesthesia during the surgery (>30 minutes)
(2) Marginal: Slight delay to procedure (<30 minutes)
(1) Negligible: No patient impact. User (physician) could notice error.
Patient Age
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Patient Sex
*
Female
Male
Intersex
Detailed description of product application
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Detailed Consequences
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What were the post operative instructions?
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Did the patient follow the post-operative instructions? If no, explain below.
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Why did the patient approach the healthcare center?
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Any further information
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X-rays (pre-, intra-, postoperative)
Surgical report
Post-operative treatment plan/report
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