MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-01 for NONE manufactured by .
[23215989]
On (b)(6) 2015, pt identified by x-ray to have s1 pedicular screw fracture. On (b)(6) 2015, pt underwent the following operative procedures: l4, l5 and s1 laminectomies and bilateral facetectomies. Harvesting of posterior spinal elements from l4, l5 and s1 for use as autograft; l4, l5 and s1 posterior segmental instrumentation using reliance medical pedicle screw system; l4, l5, and s1 posterior and posterolateral arthrodesis. . Placement of morselized autograft, vancomycin powder and allograft along the decorticated bone of l4, l5, and s1 bilaterally. Intraoperative fluoroscopy. Will contact manufacturer subsequent to this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5005260 |
| MDR Report Key | 5005260 |
| Date Received | 2015-07-01 |
| Date of Report | 2015-06-26 |
| Date of Event | 2015-06-05 |
| Date Facility Aware | 2015-06-23 |
| Report Date | 2015-06-26 |
| Date Reported to FDA | 2015-06-26 |
| Date Added to Maude | 2015-08-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | NONE |
| Product Code | MCV |
| Date Received | 2015-07-01 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-01 |