KMI TOTAL WRIST IMPLANT KMI UNIVERSAL 2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-04-18 for KMI TOTAL WRIST IMPLANT KMI UNIVERSAL 2 manufactured by Integra Lifescienses Corporation.

Event Text Entries

[16404755] In 2008, total wrist implant fractured requiring repair. Pt returned to or for damaged hardware to be removed and replaced.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5006300
MDR Report Key1031612
Date Received2008-04-18
Date of Report2008-02-20
Date of Event2008-02-20
Date Added to Maude2008-04-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameKMI TOTAL WRIST IMPLANT
Generic NameORTHOPEDIC PRODUCTS
Product CodeKWM
Date Received2008-04-18
Model NumberKMI UNIVERSAL 2
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedV
Device Sequence No1
Device Event Key1000468
ManufacturerINTEGRA LIFESCIENSES CORPORATION
Manufacturer Address311 ENTERPRISE DR PLAINSBORO NJ 08536 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2008-04-18

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