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 2017-08-10 for CENTERPIECE PLATE FIXATION SYSTEM UNK manufactured by Warsaw Orthopedics.
[82448261]
Devices of multiple part/lot numbers were implanted during the procedure including: part, lot, similar device, 510k#, upn. G9010000252, 0560102w (x1) , 853-012, k050082, (b)(4). G9010000252, 0560104w (x2), 853-012, k050082, (b)(4). G9010000258 0491227w (x1), 853-012, k050082, (b)(4). G9010000274 , 0563443w (x6), 853-465 , k050082, (b)(4). G9010000275, 0555560w (x3), 853-467, k050082, (b)(4). G9010000275 , 0556341w (x2), 853-467, k050082 , (b)(4). Although it is unknown if any of these devices contributed to the reported event, we are filing this mdr for notification purposes. H6: patient code c64343 (revision surgery). Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event.
Patient Sequence No: 1, Text Type: N, H10
[82448262]
Pre-op diagnosis: cervical spondylotic myelopathy procedure: laminoplasty levels implanted: c4-c7 it was reported that on unknown date, post-op, the patient suffered with quadriplegia after surgery. Quadriplegia started on (b)(6) 2017. Revision surgery was performed to remove the implants.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2017-01906 |
| MDR Report Key | 6783894 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-10 |
| Date of Report | 2017-07-19 |
| Date Mfgr Received | 2017-07-19 |
| Date Added to Maude | 2017-08-10 |
| 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 | 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 | 2017-08-10 |
| Model Number | NA |
| Catalog Number | UNK |
| 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 | 1. Other; 2. Required No Informationntervention | 2017-08-10 |