MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-29 for CENTERPIECE PLATE FIXATION SYSTEM G9010000274 manufactured by Warsaw Orthopedics.
[39587325]
(b)(6). (b)(4). This part is not approved for use in the united states; however, the catalog # 853-465 and 510k # (b)(4) of 'like devices' were cleared in the united states. No applicable imaging films available. Hence it is difficult to come to any conclusion.
Patient Sequence No: 1, Text Type: N, H10
[39587326]
It was reported that patient underwent laminoplasty on an unknown date. Post-op, a screw was backed-out to lamina. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1030489-2016-00560 |
MDR Report Key | 5465771 |
Date Received | 2016-02-29 |
Date of Report | 2016-02-04 |
Date Mfgr Received | 2016-02-04 |
Date Added to Maude | 2016-02-29 |
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 | 0 |
Brand Name | CENTERPIECE PLATE FIXATION SYSTEM |
Generic Name | ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL |
Product Code | NQW |
Date Received | 2016-02-29 |
Model Number | NA |
Catalog Number | G9010000274 |
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 | 2016-02-29 |