MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-17 for INFUSE BONE GRAFT 7510400 manufactured by Medtronic Sofamor Danek Usa, Inc.
[142248667]
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[142248668]
It was reported via patient call that the patient had undergone 5-level fusion. From an unknown date, post-op, she has been experiencing continued pain. She also stated that her surgeon said that her x-rays look good. Allegedly, the patient has been diagnosed with arachnoiditis and has difficulty with her legs. The patient also complained of complex region pain syndrome, flat back syndrome, major nerve damage. Reportedly, there was also extra bone growth due to which she could not receive any shots in her back for pain. The surgeon has recommended her for a revision surgery. Allegedly, while conducting tests, technician said that it was very difficult to get the needle in due to high amount of bone growth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2019-00435 |
| MDR Report Key | 8523867 |
| Report Source | CONSUMER |
| Date Received | 2019-04-17 |
| Date of Report | 2019-11-27 |
| Date Mfgr Received | 2019-10-28 |
| Device Manufacturer Date | 2014-05-14 |
| Date Added to Maude | 2019-04-17 |
| 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 | STACIE ZIEMBA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Street | 4340 SWINEA RD |
| Manufacturer City | MEMPHIS TN 38118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38118 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFUSE BONE GRAFT |
| Generic Name | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET |
| Product Code | NEK |
| Date Received | 2019-04-17 |
| Model Number | NA |
| Catalog Number | 7510400 |
| Lot Number | M111114AA6 |
| Device Expiration Date | 2015-09-30 |
| 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 | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-17 |