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 2015-10-07 for CENTERPIECE PLATE FIXATION SYSTEM UNK manufactured by Medtronic Sofamor Danek.
[27804103]
(b)(6). (b)(4). Neither the device nor applicable imaging films were returned. Hence, no conclusions can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[27804104]
It was reported that patient underwent laminoplasty with artificial plate system at levels c3-c7 on an unknown date. Post-op, csf leakage was suspected. Revision was performed. During the revision, surgeon removed a plate placed at c3 (catalog number not provided), treated csf leak, and placed another plate for the level. The product used in the patient. Patient complications were unknown. Csf leakage reported. Patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2015-02593 |
| MDR Report Key | 5134033 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-10-07 |
| Date of Report | 2015-09-15 |
| Date of Event | 2015-09-15 |
| Date Mfgr Received | 2015-09-15 |
| Date Added to Maude | 2015-10-07 |
| 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 | 2015-10-07 |
| 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 | 2015-10-07 |