TIBIALIS TENDON *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-07 for TIBIALIS TENDON * manufactured by Mtf.

Event Text Entries

[17369366] Pt received an anterior tibialis tendon transplant for a stage 3 separated shoulder performed at surgical center. A swab culture and "snippet" of the allograft were taken prior to implantation. The culture was reported as heavy growth for salmonella arizonii. It was confirmed by a public health laboratory. The pt had been put on antibiotics for surgery. Pt was placed on ciprofloxacin after the culture results were obtained. Pt was asymptomatic following transplant. Cdc, health dept. , fda, and the tissue processor, musculoskeletal transplant foundation mtf have discussed the case. A traceback of the tissue processing and a review of the tissue test results showed no deviations. Health dept also examined the surgical center and laboratory where the culture grew out and found no evidence of contamination from those sites. It was found that lab uses salmonella arizonae as quality control for a certain media. However, the two organisms were compared molecularly and found to be different. Because the event was isolated and the pt remained asymptomatic, no further action was taken.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1034571
• MDR Report Key: 571573
• Date Received: 2005-02-07
• Date of Report: 2005-02-07
• Date of Event: 2004-09-28
• Date Added to Maude: 2005-02-10
• 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: TIBIALIS TENDON
• Generic Name: *
• Product Code: LMO
• Date Received: 2005-02-07
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 561425
• Manufacturer: MTF
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2005-02-07