MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-06-10 for CENTERPIECE PLATE FIXATION SYSTEM 853-012 manufactured by Warsaw Orthopedics.
[47101246]
(b)(4). Device evaluation anticipated but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[47101247]
It was reported that patient underwent laminoplasty c4-6. Post-op, surgeon noticed that the plate at c4 was broken. As per surgeon, the facet above the plate had been impacting on it during extension, which ultimately caused the breakage of the plate. Plate was placed too close to the c3-4 facet joint so the inferior articulate process of c3 impinged on the plate in extension. Plate was explanted.
Patient Sequence No: 1, Text Type: D, B5
[48727456]
Product analysis :visual review confirms deformation and breakage of the implant. Explanting doctor observed likely physical impingement of the plate due to mislocation of the device during implantation. The above observations are consistent with mislocation of the device at initial implantation.
Patient Sequence No: 1, Text Type: N, H10
[100316971]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2016-01754 |
| MDR Report Key | 5716353 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-06-10 |
| Date of Report | 2016-07-01 |
| Date of Event | 2016-05-11 |
| Date Mfgr Received | 2016-07-01 |
| Device Manufacturer Date | 2011-10-12 |
| Date Added to Maude | 2016-06-10 |
| 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 | 2016-06-10 |
| Returned To Mfg | 2016-05-25 |
| Model Number | NA |
| Catalog Number | 853-012 |
| Lot Number | 0184113W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2016-06-10 |