FDA Adverse Event
Injury
Summary report: N
ORTHADAPT BIOIMPLANT
MDR report key: 1480330
·
Received September 18, 2009
Report
- Report Number
- 3005147058-2009-00002
- Event Type
- Injury
- Date Received
- September 18, 2009
- Date of Event
- January 15, 2009
- Report Date
- August 30, 2009
- Manufacturer
- PEGASUS BIOLOGICS, INC.
- Product Code
- FTM
- PMA / PMN Number
- K071065
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE ORTHADAPT BIOIMPLANT WAS USED OFF LABEL AS AN ATFL REPLACEMENT; ORTHADAPT BIOIMPLANTS ARE NOT INDICATED FOR THIS USE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATED THE DEVICE IDENTIFIED IN THIS REPORT MET ALL MFG REQUIREMENTS. THE MFR OF THE DEVICE AT THE TIME WAS PEGASUS BIOLOGICS, INC. SYNOVIS ORTHOPEDIC AND WOUNDCARE, INC IS THE REPORTING COMPANY FOR THE EVENT. THE EVENT OCCURRED PRIOR TO SYNOVIS ACQUIRING PEGASUS BIOLOGICS.
Description of Event or Problem · 1
A SOFT TISSUE MASS WAS NOTED OVER THE LATERAL ANKLE OF THE LEFT FOOT APPROX 10 MONTHS POST ATFL (ANTERIOR TALOFIBULAR LIGAMENT) REPLACEMENT WITH AN ORTHADAPT BIOIMPLANT, FOLLOWED BY PAIN AND INFLAMMATION APPROX 5.5 MONTHS LATER. THE MASS AND THE GRAFT WERE REMOVED 18 MONTHS POST IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHADAPT BIOIMPLANT | SURGICAL MESH | FTM | PEGASUS BIOLOGICS, INC. | OFX-2500 | POR-061222-01R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization |