MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2014-05-02 for PROGENIX(R) PLUS 006005 manufactured by Medtronic Sofamor Danek Usa, Inc.
[4383792]
It was reported that a patient underwent an anterior cervical diskectomy at c4-5, c5-6-7, anterior cervical arthrodesis at c4 to c7, anterior cervical instrumentation at c4-c7, use of allograft, use of locally harvested autograft to treat right leg numbness and heaviness. It was reported that 4. 5 years post-op that the patient was diagnosed with (b)(6) allegedly from the use of the tissue allograft implanted during this acdf procedure.
Patient Sequence No: 1, Text Type: D, B5
[11885777]
(b)(4). A review of the donor certificate of analysis for this device did not reveal any non-conformances to specification or deviations in procedure which might contribute to the reported event. Medical judgment:? (b)(6) is one of the more common acquired viral infections. The donor was fully screened before he/she was determined to be an eligible donor for human transplantation. A life style and risk analysis questionnaire was conducted with the next-of kin. Each and every donor is also tested according to the fda regulations and the aatb standards for the presence of viruses for (b)(6). Additionally, this donor had dna testing for (b)(6) and west nile virus. It was also tested for the presence of (b)(6), and a few other infectious diseases that are not required to be done. All of the testing was negative or non-reactive indicating the absence of any infectious disease at the time of death. With all these negative tests, it is medically improbable that there is any relation of the donor tissue product to be in any way related to the development of the recipient? S (b)(6), which was only discovered four to five years after the surgery. The two events are, in all medical probability, unrelated.? Products from multiple manufacturers were implanted during the procedure. Although it is unlikely that a medtronic device contributed to the reported event, we are filing this mdr for notification purposes.
Patient Sequence No: 1, Text Type: N, H10
[98455440]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2014-02400 |
| MDR Report Key | 3787879 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2014-05-02 |
| Date of Report | 2014-04-03 |
| Date of Event | 2009-09-02 |
| Date Mfgr Received | 2014-04-03 |
| Date Added to Maude | 2014-05-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | HUZEFA MAMOOLA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROGENIX(R) PLUS |
| Generic Name | FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) |
| Product Code | MBP |
| Date Received | 2014-05-02 |
| Model Number | NA |
| Catalog Number | 006005 |
| Lot Number | 1174230039 |
| Device Expiration Date | 2011-02-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-02 |