REGENERATION TECHNOLOGIES *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-15 for REGENERATION TECHNOLOGIES * manufactured by *.

Event Text Entries

[21628033] Pt underwent acl reconstruction with a cadaver graft. Pt did well initially, but then developed pain, erythema, swelling and a low-grade fever of 100. 5 degrees. Pt presented to ed on the weekend and aspiration was attempted but unsuccessful. Pt was started on a course of duricef at that time. Pt was seen by orthopedic surgeon 2 days later and an arthrocentesis was done. The results were consistent with a septic arthritis. An irrigation and debridement was performed semi-urgently. During the procedure, the acl was noted to be intact, but some of the fibers seemed to have undergone degeneration. There was no evidence of cartilage damage. The culture result showed a light growth of methicillin sensitive staph aureus. Pt was also seen by an infectious disease physician who thought the culture may be negative because of antibiotic use. He recommended a 6 week course of rocephin with followup. Followup with the manufacturer showed that all donor cultures were negative. All tissue pre and post processing cultures were without growth and with negative serologies. No incidents were reported on 5 other grafts from the same donor.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1034109
• MDR Report Key: 563865
• Date Received: 2004-11-15
• Date of Report: 2004-11-11
• Date of Event: 2004-09-20
• Date Added to Maude: 2005-01-10
• 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
• 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: REGENERATION TECHNOLOGIES
• Generic Name: ACL
• Product Code: LMO
• Date Received: 2004-11-15
• Model Number: *
• Catalog Number: *
• Lot Number: 101034519
• ID Number: 2503234
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 553594
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2004-11-15