SWANSON WRIST JOINT IMPLANT G488-0203

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2000-03-02 for SWANSON WRIST JOINT IMPLANT G488-0203 manufactured by Wright Medical Technology, Inc..

MAUDE Entry Details

Report Number1043534-2000-00014
MDR Report Key267040
Report Source06
Date Received2000-03-02
Date of Event2000-01-25
Date Mfgr Received2000-02-01
Device Manufacturer Date1994-11-01
Date Added to Maude2000-03-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Manufacturer ContactDEBBY DAURER
Manufacturer Street5677 AIRLINE RD
Manufacturer CityARLINGTON TX 38002
Manufacturer CountryUS
Manufacturer Postal38002
Manufacturer Phone9018674601
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameSWANSON WRIST JOINT IMPLANT
Generic NameSMALL JOINT COMPONENT
Product CodeKIG
Date Received2000-03-02
Model NumberNA
Catalog NumberG488-0203
Lot Number114A009551
ID NumberNA
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagY
Date Removed*
Device Sequence No1
Device Event Key258507
ManufacturerWRIGHT MEDICAL TECHNOLOGY, INC.
Manufacturer Address5677 AIRLINE RD. ARLINGTON TX * US
Baseline Brand NameSWANSON WRIST JOINT IMPLANT
Baseline Generic NameSMALL JOINT COMPONENT
Baseline Model NoNA
Baseline Catalog NoG488-0203
Baseline IDNA
Baseline Device FamilyS J 888.3780
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK850255
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2000-03-02

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