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 2014-06-27 for LUMBAR WEDGED I/F CAGE(7X9)X9X21 173121207 manufactured by Depuy Synthes Spine.
[14875967]
International affiliate reports the lumbar wedged i/f cage was broken during surgery. The cage was placed at l4/5. Since the position of the cage was not appropriate, the surgeon was adjusting the cage position with the inserter still attached to the cage in disk space. Then, it was noted that the cage was broken. No broken piece was left in the patient's body. The procedure was delayed by ten minutes and there were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
[15394609]
A follow up report will be filed upon completion of the investigation. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[26796597]
Visual verification of the returned lumbar wedged i/f cage confirmed that the cage had been fractured along the whole length of the threaded hole. A review of the device history record found no discrepancies. The lot was released accomplishing all quality requirements. A 12-month review of the complaint trend analysis for the product code noted that there were no other complaints for issues associated with the cage breakage during surgery. The root cause of the cage becoming broken during surgery cannot positively be determined. However, as noted in the accompanying instructions for use, excessive torque, when applied to long-handle insertion tools, can cause splitting or fracture of the polymer/carbon-fiber implants. When a polymer/carbon-fiber implant is impacted or hammered into place, the broad surface of the insertion tool should be carefully seated fully against the implant. Impaction forces applied directly to a small surface of the implant could cause fracture of the implant. No corrective action/preventive action (capa) is necessary at this time as there have been no issues identified in the manufacturing or release of this cage that could have contributed to the problem reported by the customer. Therefore, this complaint file will be closed with no further action required. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2014-11637 |
| MDR Report Key | 3899218 |
| Report Source | 01,05,07 |
| Date Received | 2014-06-27 |
| Date of Report | 2014-06-04 |
| Date of Event | 2014-06-04 |
| Date Mfgr Received | 2014-07-22 |
| Device Manufacturer Date | 2013-11-16 |
| Date Added to Maude | 2014-06-27 |
| 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 | 2014-06-27 |
| Returned To Mfg | 2014-07-08 |
| Catalog Number | 173121207 |
| Lot Number | 5L89B |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-06-27 |