FDA Adverse Event
Injury
Summary report: N
ORTHADAPT BIOIMPLANT
MDR report key: 1051111
·
Received May 22, 2008
Report
- Report Number
- 3005147058-2008-00004
- Event Type
- Injury
- Date Received
- May 22, 2008
- Report Date
- May 22, 2008
- Manufacturer
- PEGASUS BIOLOGICS, INC.
- Product Code
- FTM
- PMA / PMN Number
- K043388
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTED BY GENZYME ASSOCIATE MEDICAL DIR, THE PT UNDERWENT IMPLANTATION OF AUTOLOGOUS CULTURED CHONDROCYTES IN 2007. A RELATIVE OF THE PT REPORTED TO GENZYME, THE PT HAD SWELLING IN AREA AFTER CARTICEL IMPLANTATION ALONG WITH THE USE OF THE ORTHOADAPT PRODUCT. THE RELATIVE REPORTED CULTURES TAKEN WERE NEGATIVE. THE COMPANY IS ATTEMPTING TO OBTAIN ADD'L INFO ABOUT THE REPORTED EVENT; THIS EVENT IS NOT CONFIRMED AND IS BEING REPORTED FROM A CONSERVATIVE STANDPOINT. IF RELEVANT ADD'L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHADAPT BIOIMPLANT | SURGICAL MESH | FTM | PEGASUS BIOLOGICS, INC. | OFX 1000 | POR 070326-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | LIVING TISSUE| CARTICEL (AUTOLOGOUS CULTURED CHONDROCYTES) |