MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-07-14 for GRAFTON DBM NOT REPORTED manufactured by Osteotech, Inc (subsidiary Of Medtronic).
[19455428]
Neither the device nor any patient medical records or imaging studies were returned to the manufacturer for evaluation. No part number or lot information was provided; therefore, no review of the device history records was possible. The manufacturer is unable to evaluate or determine a definitive cause for the reported event.
Patient Sequence No: 1, Text Type: N, H10
[19484464]
It was reported that a surgeon had stopped using the allograft bone void filler product as a result of 'draining issues' which he is attributing to the product. Multiple attempts were made to obtain additional information, though none was provided. It is not known whether any medical or surgical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246640-2014-00008 |
| MDR Report Key | 3932677 |
| Report Source | 07 |
| Date Received | 2014-07-14 |
| Date of Report | 2014-06-23 |
| Date Mfgr Received | 2014-06-23 |
| Date Added to Maude | 2014-07-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | EDWARD WHEELER |
| Manufacturer Street | 201 INDUSTRIAL WAY WEST |
| Manufacturer City | EATONTOWN NJ 07724 |
| Manufacturer Country | US |
| Manufacturer Postal | 07724 |
| Manufacturer Phone | 7325422800 |
| Manufacturer G1 | OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) |
| Manufacturer Street | 201 INDUSTRIAL WAY WEST |
| Manufacturer City | EATONTOWN NJ 07724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07724 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRAFTON DBM |
| Generic Name | FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) |
| Product Code | MBP |
| Date Received | 2014-07-14 |
| Model Number | NOT REPORTED |
| Catalog Number | NOT REPORTED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) |
| Manufacturer Address | 201 INDUSTRIAL WAY WEST EATONTOWN NJ 07724 US 07724 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-07-14 |