MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-05-22 for GRAFTON DBM NOT REPORTED manufactured by Osteotech, Inc (subsidiary Of Medtronic).
[4500209]
A patient reported that she received allograft bone void filler during her cervical spine fusion procedure in 2007 and states that she is currently having? Difficulty swallowing, nerve pain (c6-c7 nerve root) and chronic symptoms with decreased mobility.? The patient did not provide any specific product or lot information. The patient denied having had any post-operative infection or revision procedures. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[11798688]
No medwatch form was received from the user facility, therefore, this medwatch was completed using the information provided by the initial reporter. Any missing or incomplete information is the result of the information not having been provided by the initial reporter. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2246640-2014-00004 |
| MDR Report Key | 3828204 |
| Report Source | 04 |
| Date Received | 2014-05-22 |
| Date of Report | 2014-04-23 |
| Date Mfgr Received | 2014-04-23 |
| Date Added to Maude | 2014-05-23 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | 2014-05-22 |
| 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. Deathisabilit | 2014-05-22 |