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 2019-02-20 for CENTERPIECE PLATE FIXATION SYSTEM G9010000274 manufactured by Warsaw Orthopedics.
[136758082]
This product is not marketed in us but a similar device with catalog # 853-465, udi# (b)(4) 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. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[136758083]
It was reported that the patient underwent cervical laminoplasty at c3-c6 due to cervical spondylotic myelopathy. Two weeks after the operation, it was discovered that the screw backed out at c3 lamina. It is unknown that the screw came out to what extent; but the implanted plate did not move. The product is still implanted in the patient. No patient complications have been reported yet; and the patient would be observed during follow-up visits. Doctor's comments: during the initial operation, as the grip strength of driver was too strong and the driver was hard to be removed, it was removed by shaking. This expanded the pilot hole. Additionally, it was difficult to verify the depth as the head got bigger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2019-00170 |
| MDR Report Key | 8352842 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-20 |
| Date of Report | 2019-02-20 |
| Date of Event | 2018-11-19 |
| Date Mfgr Received | 2019-01-28 |
| Device Manufacturer Date | 2018-08-24 |
| Date Added to Maude | 2019-02-20 |
| 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 | STACIE ZIEMBA |
| 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 | 2019-02-20 |
| Model Number | NA |
| Catalog Number | G9010000274 |
| Lot Number | 0670528W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-02-20 |