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 2016-02-19 for CENTERPIECE PLATE FIXATION SYSTEM UNK manufactured by Medtronic Sofamor Danek.
[38552792]
(b)(4). Neither product nor applicable imaging studies were made available. Hence, we cannot draw any conclusions. We do not know whether our product caused the adverse event. We are filing this report for notification purposes only.
Patient Sequence No: 1, Text Type: N, H10
[38552793]
It was reported that on an unknown date, postoperative infection was observed in the patient, which resulted in a revision surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2016-00495 |
| MDR Report Key | 5446497 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-02-19 |
| Date of Report | 2016-01-22 |
| Date Mfgr Received | 2016-01-22 |
| Date Added to Maude | 2016-02-19 |
| 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 |
| Product Code | NQW |
| Date Received | 2016-02-19 |
| 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 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-02-19 |