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 2018-02-16 for CENTERPIECE PLATE FIXATION SYSTEM G9010000274 manufactured by Warsaw Orthopedics.
[100235540]
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. Product was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. The following products were used in the surgery: (product id: (b)(4), lot: 0567631w, qty: 8). Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[100235541]
It was reported that the patient underwent laminoplasty at c5-c6 due to spondylotic myelopathy. Post-op, the hinge (patient's body part) side of both c5 and c6 fractured and as a result the implanted screws dropped into the spinal canal. Patient underwent revision surgery for removing the screw and also underwent posterior spinal fusion (psf) surgery at c4-c7 due to kyphosis progress. There was no defects on the implants.
Patient Sequence No: 1, Text Type: D, B5
[103654330]
Additional information: x-ray review result: c5-6 laminoplasty post-op x-ray and ct images were provided. There is a fracture of the non instrumented side of the laminoplasty and to not see a screw in the spinal cord on the provided images. Likely cause of hardware fracture is progression of deformity in the construct where fusion is not expected to occur. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2018-00239 |
| MDR Report Key | 7275991 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-16 |
| Date of Report | 2018-03-28 |
| Date Mfgr Received | 2018-02-27 |
| Device Manufacturer Date | 2017-05-11 |
| Date Added to Maude | 2018-02-16 |
| 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 | 2018-02-16 |
| Model Number | NA |
| Catalog Number | G9010000274 |
| Lot Number | 0567631W |
| 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 | 1. Other; 2. Required No Informationntervention | 2018-02-16 |