BIOSCREW UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2000-03-01 for BIOSCREW UNK manufactured by Linvatec Corp..

Event Text Entries

[19487760] Pt underwent anterior crucial ligament reconstruction with implantation of bioscrew. Approx 1 month post-operatively, pt presented with "autoimmune type disorder of peripheral nerves manifested as paresthesias, cramps and fasciculations associated with prominent fatigue". Device remains implanted in pt to date.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1017294-2000-00027
• MDR Report Key: 267006
• Report Source: 05,07
• Date Received: 2000-03-01
• Date of Report: 2000-02-01
• Date of Event: 1999-01-01
• Date Mfgr Received: 2000-02-01
• Date Added to Maude: 2000-03-07
• 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: 0
• Manufacturer Contact: ROGER MURPHY
• Manufacturer Street: 11311 CONCEPT BLVD
• Manufacturer City: LARGO FL 33773
• Manufacturer Country: US
• Manufacturer Postal: 33773
• Manufacturer Phone: 7273995205
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BIOSCREW
• Generic Name: ABSORBABLE INTERFERENCE SCREW
• Product Code: MBJ
• Date Received: 2000-03-01
• Model Number: NA
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 258480
• Manufacturer: LINVATEC CORP.
• Manufacturer Address: 11311 CONCEPT BLVD. LARGO FL 33773 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2000-03-01