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 2013-07-24 for LUMBAR WEDGED I/F CAGE(7X9)X9X21 173121207 manufactured by Depuy Synthes Spine.
[3619434]
The lumbar cage was inserted in l4-5 and its correct position was confirmed. Following that, a second lumbar cage was inserted in l4-5 and after the procedure, while still in the operating room, it was noted that the first cage was protruding anteriorly. The surgery had been completed and there was no additional procedure by surgeon? S decision. Per the affiliate, the surgeon said that the first cage was pushed by inserting of the second cage.
Patient Sequence No: 1, Text Type: D, B5
[10960794]
A follow up report will be filed upon completion of the investigation. Device remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[15663903]
The complaint sample was not returned for evaluation. A device history record review could not be conducted as the lot number of the device is unknown. A review of the trend analysis found no observed trends for issues of this nature. Without a product sample, we are unable to confirm the reported issue or identify the root cause. As such, this complaint will be closed with no further action required. If the complaint product sample becomes available, the complaint file will be re-opened and product evaluated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2013-22041 |
| MDR Report Key | 3245778 |
| Report Source | 01,05,07 |
| Date Received | 2013-07-24 |
| Date of Report | 2013-07-05 |
| Date of Event | 2013-07-05 |
| Date Mfgr Received | 2013-07-05 |
| Date Added to Maude | 2013-07-24 |
| 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 | BETH BECOTTE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283575 |
| 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 | 2013-07-24 |
| Catalog Number | 173121207 |
| Lot Number | UNK |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2013-07-24 |