MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-30 for UNK manufactured by Medtronic Sofamor Danek.
[32465323]
Literature citation:takashi adachi, taketoshi kushida, jun ikeura, hirokazu iida. "experience of unilateral open-door cervical laminoplasty using plate fixation system (centerpiecetm)". A2: mean age of patients was 70. 6 years. (b)(6) (b)(4). 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.
Patient Sequence No: 1, Text Type: N, H10
[32465324]
It was reported in an abstract that comparison study of pf (plate fixation) group and ha (ha spacer) group (details described below) was conducted for examining expansion rate of intervertebral disc, blood loss amount, surgical time, and post-op complications of each group. It was reported that one screw back-out from lateral mass at c5 was observed in case of pf group, postoperatively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2015-03188 |
| MDR Report Key | 5255898 |
| Date Received | 2015-11-30 |
| Date of Report | 2015-10-27 |
| Date Mfgr Received | 2015-10-27 |
| Date Added to Maude | 2015-11-30 |
| 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 | GREG ANGLIN |
| 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 | 0 |
| Generic Name | ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL |
| Product Code | NQW |
| Date Received | 2015-11-30 |
| 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 |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-30 |