MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07,company representative, report with the FDA on 2013-06-27 for GRAFTON DBM A43110 manufactured by Osteotech, Inc. (subsidiary Of Medtronic).
[3472573]
Patient reported that she had had allograft bone void filler and metal instrumentation implanted during a posterior cervical fusion, and 6 weeks after her surgery, she developed and has had a rash and? Lump? In the back of her neck directly over the instrumentation. Patient stated she is following up with a dermatologist to determine if she is experiencing an allergic reaction. Patient stated she did not develop any post-operative infection.
Patient Sequence No: 1, Text Type: D, B5
[10926937]
This medwatch report was completed using the information provided by the initial reporter. Any missing or incomplete data is the result of the information not having been provided by the initial reporter. Multiple devices were implanted during the reported procedure. Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes. (b)(6). (b)(4). Review of the manufacturing records for the subject device indicated that the product was manufactured per procedure and met all required specifications. Medtronic has not received any additional reports of this nature involving any other product manufactured from this donor tissue. The subject product was part of the above there was no report of any post-operative infection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2246640-2013-00020 |
| MDR Report Key | 3193124 |
| Report Source | 04,07,COMPANY REPRESENTATIVE, |
| Date Received | 2013-06-27 |
| Date of Report | 2013-05-29 |
| Date Mfgr Received | 2013-05-29 |
| Date Added to Maude | 2013-06-27 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD WHEELER |
| Manufacturer Street | 51 JAMES WAY |
| Manufacturer City | EATONTOWN NJ 07724 |
| Manufacturer Country | US |
| Manufacturer Postal | 07724 |
| Manufacturer Phone | 7325422800 |
| Manufacturer G1 | OSTEOTECH, INC. (SUBSIDIARY OF MEDTRONIC |
| Manufacturer Street | 51 JAMES WAY |
| Manufacturer City | EATONTOWN NJ 07724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07724 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2246640-042612-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRAFTON DBM |
| Generic Name | BONE GRAFTING MATERIAL, HUMAN SOURCE |
| Product Code | NUN |
| Date Received | 2013-06-27 |
| Model Number | A43110 |
| Catalog Number | A43110 |
| Lot Number | OTSCT0833554035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOTECH, INC. (SUBSIDIARY OF MEDTRONIC) |
| Manufacturer Address | 51 JAMES WAY EATONTOWN NJ 07724 US 07724 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-06-27 |