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 2018-02-22 for CENTERPIECE PLATE FIXATION SYSTEM G9010000274 manufactured by Warsaw Orthopedics.
[100793995]
This product is not marketed in us but a similar device with catalog # 853-465, 510k# k050082 and upn (b)(4) is approved for sale in us. Product was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the r eported event. X-ray review: post op x ray c3-6 laminoplasty show placement of centerpiece laminoplasty plate. There is back out of the c4 lamina screw opposite to the facet screw. This is predictable for laminoplasty given fusion is not expected to occur. The operation is probably not necessary. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[100793996]
It was reported that patient was pre-operatively diagnosed with cerebral spinal meningitis and underwent laminoplasty at c3-6. Post-op, the x-ray report revealed the screw back out at c4 and c6 on (b)(6) 2018. No patient complications reported as the result of the event
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2018-00257 |
| MDR Report Key | 7288152 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-22 |
| Date of Report | 2018-02-22 |
| Date of Event | 2018-01-30 |
| Date Mfgr Received | 2018-01-30 |
| Date Added to Maude | 2018-02-22 |
| 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 | 2018-02-22 |
| Model Number | NA |
| Catalog Number | G9010000274 |
| Lot Number | UNK |
| 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 | 2018-02-22 |