BIOMET *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-05-01 for BIOMET * manufactured by Biomet, Inc..

Event Text Entries

[16621250] Index finger digital nerve injured during procedure.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1013709
• MDR Report Key: 165712
• Date Received: 1998-05-01
• Date of Report: 1998-04-20
• Date of Event: 1998-02-09
• Date Added to Maude: 1998-05-06
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BIOMET
• Generic Name: INDIANA TOME
• Product Code: EKD
• Date Received: 1998-05-01
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 161262
• Manufacturer: BIOMET, INC.
• Manufacturer Address: AIRPORT INDUSTRIAL PARK WARSAW IN 46580 US
• Baseline Brand Name: INDIANA TOME
• Baseline Generic Name: INSTRUMENT, MANUAL, SURGICA
• Baseline Model No: NA
• Baseline Catalog No: 200060
• Baseline ID: NA
• Baseline Device Family: INDIANA TOME
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1998-05-01