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 2014-01-29 for JAGUAR LUMBAR WEDGED I/F CAGE 173123209 manufactured by Depuy Synthes Spine.
[4068404]
It was reported that the physician found it difficult to the cage into the vertebral body, and so the cage with inserter was moved cephalocaudal. The cage broke cleanly into two pieces with one piece remaining on the inserter, and the other at the vertebral body. The pieces were removed and fit together perfectly, so the physician reports no fine fragments were lost within the patient. Another product was used to complete the case with a 20 minutes delay to the surgery time. No adverse patient consequences to the patient were reported.
Patient Sequence No: 1, Text Type: D, B5
[11613202]
A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[29339831]
Visual inspection noted that the cage had been broken into 2 solid segments. A review of the device history record for the lumbar cage found no discrepancies during the manufacturing of the product. No issues were identified during the manufacturing and release of this product that could have been contributed to the problem reported by the customer. The product was released accompanying all quality requirements. A 12-month review of the complaint trend analysis for the lumbar cage was conducted on the specific product code from this complaint as the height of the implant affects the stress profile on insertion and therefore this height is not indicative of the family or vice versa. It was noted that there were no related complaints for issues of this nature. The root cause of the lumbar cage breakage 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 is required as there has been no issue identified in the manufacturing or release of this device, and there have been no systematic trends. Therefore, this complaint will be closed with no further action required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2014-11229 |
| MDR Report Key | 3596462 |
| Report Source | 01,05,07 |
| Date Received | 2014-01-29 |
| Date of Report | 2014-01-07 |
| Date of Event | 2014-01-07 |
| Date Facility Aware | 2014-01-07 |
| Date Mfgr Received | 2014-01-07 |
| Device Manufacturer Date | 2009-09-10 |
| Date Added to Maude | 2014-01-29 |
| 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 | 0 |
| 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 | JAGUAR LUMBAR WEDGED I/F CAGE |
| Generic Name | SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM |
| Product Code | MCV |
| Date Received | 2014-01-29 |
| Returned To Mfg | 2014-01-27 |
| Catalog Number | 173123209 |
| Lot Number | K5609 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2014-01-29 |