SILASTIC H.P. 100 SWANSON WRIST JOINT IMPLANT 4880202

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 1998-03-17 for SILASTIC H.P. 100 SWANSON WRIST JOINT IMPLANT 4880202 manufactured by Dow Corning Corp..

Event Text Entries

[95889] Explantation of left wrist prosthesis (silastic) due to rupture/fracture of prosthesis.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1816403-1998-00128
• MDR Report Key: 157688
• Report Source: 06
• Date Received: 1998-03-17
• Date of Report: 1998-02-09
• Date of Event: 1998-02-05
• Date Facility Aware: 1998-02-05
• Report Date: 1998-02-09
• Date Mfgr Received: 1998-02-19
• Device Manufacturer Date: 1996-11-01
• Date Added to Maude: 1998-03-20
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SILASTIC H.P. 100 SWANSON WRIST JOINT IMPLANT
• Generic Name: WRIST JOINT IMPLANT
• Product Code: KWM
• Date Received: 1998-03-17
• Returned To Mfg: 1998-02-09
• Model Number: NA
• Catalog Number: 4880202
• Lot Number: HH106280
• ID Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: 9 YR
• Device Eval'ed by Mfgr: Y
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 153635
• Manufacturer: DOW CORNING CORP.
• Manufacturer Address: 2200 WEST SALZBURG RD AUBURN MI 48611 US
• Baseline Brand Name: SILASTIC H.P. 100 SWANSON WRIST JOINT IMPLANT
• Baseline Generic Name: MAMMARY IMPLANT
• Baseline Model No: NA
• Baseline Catalog No: 4880202
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1998-03-17