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 2018-03-01 for CENTERPIECE PLATE FIXATION SYSTEM G9010000274 manufactured by Warsaw Orthopedics.
[101297059]
This product is not marketed in us but a similar device with catalog # 853-465 ,510k# k050082 and upn# (b)(4) is approved for sale in us. H6:neither the product nor applicable imaging films were returned to manufacturer for evaluation therefore we cannot determine the definitive cause of event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[101297060]
Pre-operative diagnosis for this procedure: csm it was reported that the patient underwent surgery on (b)(6) 2017. Post-op, the laminar screw at c6 backed out. Revision surgery was performed where the screw was removed on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
[106270551]
Below lot numbers were provided but it is unknown which is the correct lot number of the product. 0564547w, 0566191w, 0575203w, 0575205w, 0581616w. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2018-00302 |
| MDR Report Key | 7306923 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-01 |
| Date of Report | 2018-04-13 |
| Date of Event | 2017-10-28 |
| Date Mfgr Received | 2018-03-15 |
| Device Manufacturer Date | 2017-05-04 |
| Date Added to Maude | 2018-03-01 |
| 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 | 2018-03-01 |
| Model Number | NA |
| Catalog Number | G9010000274 |
| Lot Number | 0564547W |
| 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 | 2018-03-01 |