MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2013-08-26 for GRAFTON DBM ORTHOBLEND A44150 manufactured by Osteotech, Inc (subsidiary Of Medtronic).
[3649168]
It was reported that a patient had received allograft bone void filler during spinal surgery, and approximately 26 months later was experiencing severe pain. The patient reportedly has had 'three back surgeries," and it is not known how many, or which of the three surgeries, involved the allograft bone void filler. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[11019849]
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. (b)(6). (b)(4). The manufacturing records for the subject lot were reviewed, and 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 grafts manufactured from this lot or donor. Although it is unknown if the subject device contributed to the reported event, we are filing this mdr for notification purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2246640-2013-00021 |
| MDR Report Key | 3308396 |
| Report Source | 04,07 |
| Date Received | 2013-08-26 |
| Date of Report | 2013-08-08 |
| Date Mfgr Received | 2013-08-08 |
| Date Added to Maude | 2013-08-26 |
| 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 FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRAFTON DBM ORTHOBLEND |
| Generic Name | BONE GRAFTING MATERIAL, HUMAN SOURCE |
| Product Code | NUN |
| Date Received | 2013-08-26 |
| Model Number | A44150 |
| Catalog Number | A44150 |
| Lot Number | OTSCT1013834093 |
| 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 | 51 JAMES WAY EATONTOWN NJ 07724 US 07724 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-08-26 |