MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-03-10 for TITANIUM CEMENT RESTRICTOR MATERIAL PEEK XIB0603003 manufactured by Medtronic Sofamor Danek Usa, Inc.
[5448484]
It was reported that on (b)(6) 2004 the patient was admitted with pre-op diagnosis of discogenic pain l4-5 with stenosis and underwent discectomy l4-5, transverse lumbar interbody fusion l4-5 utilizing peek interbody device with bone morphogenetic protein and local bone allograft, stabilization of l4-5 utilizing pedicle screws l4, l5 bilaterally, and interfaced fusion l4, l5, completing 360 fusion. A burrito of bone morphogenetic protein and local bone autograft was placed across the midline of the disk space. This was then augmented by further autograft bone anteriorly and to the left and the peek spacer was then inserted with bone morphogenetic protein and allograft within it. Ap and lateral views verified satisfactory position. Intraoperative nerve monitoring was performed. There were no noted complications. The patient developed postoperative anemia. On (b)(6) 2004 the patient was discharged home. A ct scan (no date provided) reportedly indicated that the left-side had? An inadequate facetectomy at this level and that the interspace spacer had backed out and persisted in the canal and the foramen with irritation of the neural elements. There was also excessive bony growth in the canal?? On (b)(6) 2006 the patient presented with left-sided l5 radiculopathy and weakness, loosened pedicle screws, unanticipated bony overgrowth, and a partially backed out interbody device. The patient? S pre-operative diagnosis was post laminectomy lumbar syndrome, lumbar radiculopathy secondary to failed interbody spacer, scar formation and significant bone morphogenetic protein over bony growth over the foramina of l4 and l5. The patient underwent redo left removal of sextant screws and rod with replacement of sextant screws on the left at l4 and l5 and rod system, redo discectomy and takedown of fusion mass at l4 and l5 on the left, removal of partial backing out of interbody spacer, complete foraminotomies of the l4 and l5 root on the left, replacement of hardware on l4 and l5 on the left, right l4-5 posterior spinal fusion with bone morphogenetic protein (bmp) and local bone autograft. Per the operative report, the screws? Were noted to be loosened bilaterally? Spacer was identified and could not be pounded in deeply with reverse-angle curettage secondary to excessive bony and hard fusion. Using the ama drill, several holes were punched into the capstone at which time it could be fractured. At the time of the fracture, it was pounded deeply in the lateral recesses so that it could not be bending on any neural elements.?
Patient Sequence No: 1, Text Type: D, B5
[13011468]
(b)(6). (b)(4). 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. Products from multiple manufacturers were implanted during the procedure. Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2015-00497 |
| MDR Report Key | 4587250 |
| Report Source | 04 |
| Date Received | 2015-03-10 |
| Date of Report | 2015-02-10 |
| Date Mfgr Received | 2015-02-10 |
| Date Added to Maude | 2015-03-10 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HUZEFA MAMOOLA |
| 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 | TITANIUM CEMENT RESTRICTOR MATERIAL PEEK |
| Generic Name | PROSTHESIS, HIP, CEMENT RESTRICTOR |
| Product Code | JDK |
| Date Received | 2015-03-10 |
| Model Number | NA |
| Catalog Number | XIB0603003 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-10 |