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 2017-01-13 for CENTERPIECE PLATE FIXATION SYSTEM G9010000252 manufactured by Warsaw Orthopedics.
[64712624]
Devices of multiple part/lot numbers were implanted during the procedure including: part: g9010000252 / lot: unk (x3) although it is unknown if any of these devices contributed to the reported event, we are filing this mdr for notification purposes. These parts are not approved for use in the united states; however, the catalog #s 853-012, 853-467, and 853-471 and 510k # k050082 of 'like devices' were cleared in the united states. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[64712625]
It was reported that on (b)(6) 2016 patient underwent surgery. Post-op, on (b)(6) 2016, when patient visited for follow-up, exudate was observed from surgical site. As infection was suspected, cleaning of the site, removal of the implants and laminectomy were performed. Patient complications were reported unknown. The hospital considered that the infection is not related with intraoperative factors because the infection was after removal of stitches. Patient's date of discharge is uncertain because of wound cleaning due to infection and performing laminectomy. No product malfunction reported.
Patient Sequence No: 1, Text Type: D, B5
[98440784]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2017-00085 |
| MDR Report Key | 6248732 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-01-13 |
| Date of Report | 2016-12-19 |
| Date of Event | 2016-12-17 |
| Date Mfgr Received | 2016-12-19 |
| Date Added to Maude | 2017-01-13 |
| 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 | 2017-01-13 |
| Model Number | NA |
| Catalog Number | G9010000252 |
| Lot Number | UNK |
| 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. Required No Informationntervention | 2017-01-13 |