TISSUE BANKS INTERNATIONAL *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-30 for TISSUE BANKS INTERNATIONAL * manufactured by Tissue Banks International.

Event Text Entries

[15617725] Pt returned to surgery after an implant of a tibial allograft.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1033869
• MDR Report Key: 562122
• Date Received: 2004-11-30
• Date of Report: 2004-11-30
• Date of Event: 2004-09-11
• Date Added to Maude: 2004-12-30
• 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: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• 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: TISSUE BANKS INTERNATIONAL
• Generic Name: TIBIALIS TENDON ALLOGRAFT
• Product Code: LMO
• Date Received: 2004-11-30
• Model Number: *
• Catalog Number: *
• Lot Number: SFO404054016
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 551838
• Manufacturer: TISSUE BANKS INTERNATIONAL
• Manufacturer Address: * SAN RAFAEL CA * US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-11-30