MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-06-08 for CENTERPIECE? PLATE FIXATION SYSTEM G9010000274 manufactured by Warsaw Orthopedics.
[46777903]
This product is not marketed in us but a similar device with catalog # 853-465 and 510k# k050082 is approved for sale in us. Neither the product nor applicable imaging films were returned to manufacturer for evaluation therefore we cannot determine the definitive cause of event.
Patient Sequence No: 1, Text Type: N, H10
[46777904]
It was reported that patient with cervical spondylotic myelopathy underwent a spinal procedure. Post op on an unknown date the screw of lamina migrated. Revision was not scheduled. Patient complications were reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
[100615672]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2016-01704 |
| MDR Report Key | 5705673 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-06-08 |
| Date of Report | 2016-05-18 |
| Date Mfgr Received | 2016-05-18 |
| Device Manufacturer Date | 2015-10-06 |
| Date Added to Maude | 2016-06-08 |
| 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 | WARSAW ORTHOPEDICS |
| Manufacturer Street | 2500 SILVEUS CROSSING |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| 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 | 2016-06-08 |
| Model Number | NA |
| Catalog Number | G9010000274 |
| Lot Number | 0427454W |
| 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 | 2016-06-08 |