FDA Adverse Event
Injury
Summary report: N
ORTHADAPT BIOIMPLANT
MDR report key: 1051114
·
Received May 22, 2008
Report
- Report Number
- 3005147058-2008-00001
- Event Type
- Injury
- Date Received
- May 22, 2008
- Date of Event
- August 30, 2007
- 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. GENZYME COMPANY REP REPORTED THE PT DEVELOPED INFLAMMATION, SWELLING, EFFUSION AND A HIGH WHITE BLOOD CELL COUNT AFTER CARTICEL IMPLANTATION. GENZYME REPORTED AN ORTHADAPT PRODUCT WAS USED DURING THE IMPLANTATION. A "WASH OUT" PROCEDURE WAS PERFORMED ON THE PT. THE CULTURE WAS NEGATIVE. THIS EVENT HAS NOT BEEN CONFIRMED AND IS BEING REPORTED FROM A CONSERVATIVE STANDPOINT. WHEN ADD'L RELEVANT 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 1100 | POR 070305-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other | LIVING TISSUE| CARTICEL (AUTOLOGOUS CULTURED CONDROCYTES) |