MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-06-04 for LUMBAR WEDGED I/F CAGE (7X9)X9X21 173121207 manufactured by Depuy Synthes Spine.
[4656713]
It was reported that spinal devices were implanted at l5/s on (b)(6) 2014. The reconstruction/revision surgery was conducted on (b)(6) 2014 since the lumber i/f cage was found to have backed out. It was also found by the x-ray that two expedium single inner set screws had loosened which may have caused the cage to back out. No samples are being returned for evaluation as the products were implanted in the patient again. The following mfg medwatch reports are being filed for the two set screws that had loosened and the cage that had backed out: 1526439-2014-11561? Expedium single inner set screw; 1526439-2014-11562? Lumbar i/f cae; 1526439-2014-11563? Expedium single inner set screw.
Patient Sequence No: 1, Text Type: D, B5
[11808220]
Additional narrative: a complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device was re-implanted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2014-11562 |
| MDR Report Key | 3849606 |
| Report Source | 01,05,07 |
| Date Received | 2014-06-04 |
| Date of Report | 2014-05-16 |
| Date of Event | 2014-05-16 |
| Date Mfgr Received | 2014-05-16 |
| Date Added to Maude | 2014-06-04 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | ANITA BARNICK |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283583 |
| Manufacturer G1 | DEPUY SYNTHES SPINE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMBAR WEDGED I/F CAGE (7X9)X9X21 |
| Generic Name | SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM |
| Product Code | MCV |
| Date Received | 2014-06-04 |
| Catalog Number | 173121207 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-04 |