MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-02-06 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc.
[135351319]
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
[135351320]
Pre-op diagnosis: scoliosis (6 patients), degenerative disc disease (2 patients) procedure: lateral lumbar interbody fusion (llif) it was reported in the literature titled? Three-dimensional computed tomography-based spinal navigation in minimally invasive lateral lumbar interbody fusion: feasibility, technique, and initial results? That multiple patients were treated with rhbmp-2 packed into the disk space and interbody cage. Postoperative neurological deficits were recorded. Of the 8 patients analyzed, 6 were women, and the mean age was 66 years. A mean 2. 8 levels were treated. Of the 22 interbody cages placed, 12 (54. 5%) were placed in quarters 1 to 2 and 10 (45. 5%) were placed in quarters 2 to 3. One patient had groin pain after surgery, which resolved. One more patient had bilateral thigh pain and one had right thigh pain, both of which resolved by the patients? 1-month follow-up visits. Another patient had a normal neurological examination after surgery but later developed diplopia followed by weakness in all of his extremities. Patient was diagnosed with a miller-fisher variant of an acute inflammatory demyelinating polyradiculo-neuropathy and was treated by plasmapheresis with subsequent complete resolution of symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2019-00116 |
| MDR Report Key | 8313585 |
| Report Source | LITERATURE |
| Date Received | 2019-02-06 |
| Date of Report | 2019-02-06 |
| Date Mfgr Received | 2019-02-07 |
| Date Added to Maude | 2019-02-06 |
| 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 | 2019-02-06 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Other | 2019-02-06 |