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 2017-12-21 for CENTERPIECE PLATE FIXATION SYSTEM UNK manufactured by Warsaw Orthopedics.
[95450556]
Although it is unknown which of the products caused or contributed to the reported event, we are filling this mdr for notification purpose. Multiple products were used in the event which are as follows: part# , lot# , qty , similar product , 510k# , upn. (b)(4). Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Patient Sequence No: 1, Text Type: N, H10
[95450557]
It was reported that the patient presented with cervical spondylotic radiculopathy and underwent laminoplasty at c3-7. Post-op, paralysis at c5 was developed and gradually worsened without any improvement. The patient could not raise her left shoulder. The implanted plate was removed to open up the intervertebral foramen. Removal and decompressions were also performed. Hospitalization was necessary due to removal implant and decompression procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2017-02527 |
| MDR Report Key | 7137156 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-12-21 |
| Date of Report | 2017-12-21 |
| Date Mfgr Received | 2017-11-24 |
| Device Manufacturer Date | 2017-07-27 |
| Date Added to Maude | 2017-12-21 |
| 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 | 2017-12-21 |
| Model Number | NA |
| Catalog Number | UNK |
| 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 | 1. Other; 2. Required No Informationntervention | 2017-12-21 |