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 2015-11-20 for CENTERPIECE PLATE FIXATION SYSTEM UNK manufactured by Medtronic Sofamor Danek.
[31672603]
(b)(6). (b)(4). Neither device nor applicable imaging studies available. Hence, it is difficult to draw any conclusion.
Patient Sequence No: 1, Text Type: N, H10
[31672604]
It was reported that the patient underwent laminoplasty at levels c3-c6 to treat ossification of posterior longitudinal ligament. On an unknown date post-op, leakage of cerebrospinal fluid was suspected. Revision was performed to replace a plate on c4. Patient complications were reported unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2015-03086 |
| MDR Report Key | 5238369 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-11-20 |
| Date of Report | 2015-10-31 |
| Date of Event | 2015-10-31 |
| Date Mfgr Received | 2015-10-31 |
| Date Added to Maude | 2015-11-20 |
| 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 | 2015-11-20 |
| 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 | 2015-11-20 |