MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,company representati report with the FDA on 2015-06-09 for CENTERPIECE PLATE FIXATION SYSTEM G9010000274 manufactured by Warsaw Orthopedics.
[16187871]
It was reported that on (b)(6) 2015, a patient underwent an emergency spinal surgery at c3-5 levels with three plate on due to injury in a fall. Post-op, a screw on lamina side of a plate was displaced. The patient complications were unknown. The revision surgery to remove the implant will be performed. The screw displaced is c3 screw of lamina side. Ct image of routine follow-up on 2015-(b)(6) found the screw moved to near skin. The surgeon told that operation to remove a drain during surgery may cause the screw displacement. Symptoms of initial diagnosis was improved and no complication related to the displacement was observed. The revision had been scheduled with a local anesthesia on (b)(6) but it had been changed to (b)(6) and with a general anesthesia because the screw had moved to ventral side.
Patient Sequence No: 1, Text Type: D, B5
[16396055]
(b)(4). Neither device nor applicable studies received which could help us draw any conclusion.
Patient Sequence No: 1, Text Type: N, H10
[100169283]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2015-01136 |
| MDR Report Key | 4825975 |
| Report Source | 01,05,07,COMPANY REPRESENTATI |
| Date Received | 2015-06-09 |
| Date of Report | 2015-05-13 |
| Date of Event | 2015-05-11 |
| Date Mfgr Received | 2015-05-13 |
| Date Added to Maude | 2015-06-09 |
| 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 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| 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 | 2015-06-09 |
| Model Number | NA |
| Catalog Number | G9010000274 |
| Lot Number | NA |
| 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 | 2015-06-09 |