MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-12-20 for GRAFTON DBM A43102 manufactured by Osteotech, Inc (subsidiary Of Medtronic).
[4123008]
Patient stated that he had received allograft bone void filler to "fill the void in the cage" during an acdf spinal surgery in (b)(6) 2010, and that he is currently (approx 37 months post-op) experiencing pain, and was recently diagnosed with "some sort of autoimmune condition that may or may not be related" to his implant. Patient did not report having had any revision procedure following the initial surgery. He went on to say that "devices and biologics can manifest infections at any given time," and suggested that was part of his problem. He denied having had any fever or infection post-operatively, however, stating he was having "weird symptoms" that no one could explain, including continued aches and pains in his neck.
Patient Sequence No: 1, Text Type: D, B5
[11306186]
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)(4). Review of manufacturing records 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 in the subject lot, or from this donor tissue. The manufacturer's medical director has concluded that the processed donor tissue is immunologically inert, and would not cause or contribute to the patient's self-reported autoimmune symptoms. The subject product was part of the above-referenced voluntary recall.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2246640-2013-00030 |
| MDR Report Key | 3531443 |
| Report Source | 04 |
| Date Received | 2013-12-20 |
| Date of Report | 2013-11-21 |
| Date Mfgr Received | 2013-11-21 |
| Date Added to Maude | 2013-12-20 |
| 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 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0083-2013 |
| 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 | 2013-12-20 |
| Model Number | A43102 |
| Catalog Number | A43102 |
| Lot Number | OTSCT0821204092 |
| 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 | 2013-12-20 |