MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-10-06 for OSTEOFILL ICM MOLDABLE STRIP 002350 manufactured by Regeneration Technologies, Inc..
[406053]
Cervical c6-7 open reduction with internal fixation with posterior spinal fusion. Osteofill 50 mm strip implanted. Infection diagnosed 2005.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002719998-2005-00012 |
| MDR Report Key | 640223 |
| Report Source | 08 |
| Date Received | 2005-10-06 |
| Date of Report | 2005-10-05 |
| Date of Event | 2005-09-08 |
| Date Mfgr Received | 2005-09-15 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2005-10-13 |
| 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 | 0 |
| Manufacturer Contact | AUDRA MCCONNELL |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSTEOFILL ICM MOLDABLE STRIP |
| Generic Name | ALLOGRAFT BONE PASTE |
| Product Code | LMO |
| Date Received | 2005-10-06 |
| Model Number | 002350 |
| Catalog Number | 002350 |
| Lot Number | 101030790 |
| ID Number | NA |
| Device Expiration Date | 2009-09-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 629731 |
| Manufacturer | REGENERATION TECHNOLOGIES, INC. |
| Manufacturer Address | * ALACHUA FL * US |
| Baseline Brand Name | OSTEOFILL ICM MOLDABLE STRIP |
| Baseline Generic Name | ALLOGRAFT BONE PASTE |
| Baseline Model No | 002350 |
| Baseline Catalog No | 002350 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-10-06 |