MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,company representati report with the FDA on 2015-06-24 for CENTERPIECE PLATE FIXATION SYSTEM UNKNOWN manufactured by Warsaw Orthopedics.
[22513491]
(b)(6). (b)(4). I looked it up in the fda website using the keyword centerpiece. Neither device nor applicable imaging studies available. Therefore, we are unable to determine the definitive cause of the reported event.
Patient Sequence No: 1, Text Type: N, H10
[22513492]
It was reported that patient underwent laminoplasty on an unknown date at unspecified cervical levels. On an unknown date post-op, screw was found to be backed out. No patient complications were reported. The initial surgery was performed on c3-c6 on "(b)(6)". Part and lot number of the centerpiece device used were not provided. About a week post-op, a screw placed on cranial side of c3 lateral mass was found to be backed out. "80% of the screw" came out from plate. Patient had no symptom associated with the event. No additional treatment was scheduled. Surgeon did not provide any comments about the event.
Patient Sequence No: 1, Text Type: D, B5
[100600376]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2015-01279 |
| MDR Report Key | 4864553 |
| Report Source | 01,05,07,COMPANY REPRESENTATI |
| Date Received | 2015-06-24 |
| Date of Report | 2015-06-03 |
| Date Mfgr Received | 2015-06-03 |
| Date Added to Maude | 2015-07-20 |
| 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 |
| 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 | 3 |
| Brand Name | CENTERPIECE PLATE FIXATION SYSTEM |
| Generic Name | ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL |
| Product Code | NQW |
| Date Received | 2015-06-24 |
| Model Number | NA |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WARSAW ORTHOPEDICS |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-24 |