MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2005-04-08 for OPTEFORM ALLOGRAFT DISC 002545 600-05-45 manufactured by Regeneration Technologies, Inc..
[378304]
Patient underwent a repair of a non-union heel fracture. 7-10 post surgery the patient experienced an inflammatory response which the physician treated with iv antibiotics. Cultures were taken; lab work was ok. At this time the patient is still presenting with a red, inflammatory response", per complaint form. The allograft was implanted in 2004. The surgeon indicated that the surgeon indicated that the surgery site was not cultured and the pt is currently on steroid therapy. Patient has undergone a previous surgery that did not heal properly due to patient non-compliance, which warranted this procedure utilizing the opteform allograft disc and a distal tibia autograft. The surgery site from the autograft was without signs or symptoms of infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002719998-2005-00004 |
| MDR Report Key | 589176 |
| Report Source | 05,06,08 |
| Date Received | 2005-04-08 |
| Date of Report | 2005-04-08 |
| Date of Event | 2005-01-07 |
| Date Mfgr Received | 2005-03-30 |
| Device Manufacturer Date | 2003-10-01 |
| Date Added to Maude | 2005-04-11 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 11621 RESEARCH CIRCLE P.O. BOX 2650 |
| Manufacturer City | ALACHUA FL 32616 |
| Manufacturer Country | US |
| Manufacturer Postal | 32616 |
| Manufacturer Phone | 3864188888 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTEFORM ALLOGRAFT DISC |
| Generic Name | ALLOGRAFT PASTE |
| Product Code | LMO |
| Date Received | 2005-04-08 |
| Model Number | 002545 |
| Catalog Number | 600-05-45 |
| Lot Number | 101031736 |
| ID Number | NA |
| Device Expiration Date | 2008-10-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 579024 |
| Manufacturer | REGENERATION TECHNOLOGIES, INC. |
| Manufacturer Address | * GAINESVILLE FL * US |
| Baseline Brand Name | OPTEFORM ALLOGRAFT DISC |
| Baseline Generic Name | ALLOGRAFT PASTE |
| Baseline Model No | 002545 |
| Baseline Catalog No | 600-05-45 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-04-08 |