MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-03-26 for ANCHOR FS? FACET SCREW PFF0040 manufactured by Medtronic Sofamor Danek Usa, Inc.
[21997205]
It was reported that a patient underwent a l5-s1 revision tlif in which a percutaneous reduction system was utilized on one side of l5-s1 and a facet fixation system screw on the other. Approximately one month post-op, the patient complained of pain at a follow up visit and it was discovered that the facet screw had broken. The physician stated there was no traumatic event that precipitated the event. A revision surgery was performed 52 days post-op and pedicle screws were implanted at l5-s1 on the side of the broken facet screw. According to the report, the physician elected to not remove the broken facet screw as it was believed to be too difficult and would cause too much stress at that level. No further patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[22306373]
(b)(4). X-ray interpretation: "image shows the screw across the l5/s facet with the screw broken within the joint space. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2014-01961 |
| MDR Report Key | 3701254 |
| Report Source | 05,07 |
| Date Received | 2014-03-26 |
| Date of Report | 2014-02-25 |
| Date Mfgr Received | 2014-02-25 |
| Device Manufacturer Date | 2012-09-12 |
| Date Added to Maude | 2014-03-26 |
| 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 | 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 | ANCHOR FS? FACET SCREW |
| Generic Name | SYSTEM, FACET SCREW SPINAL DEVICE |
| Product Code | MRW |
| Date Received | 2014-03-26 |
| Model Number | NA |
| Catalog Number | PFF0040 |
| Lot Number | 2313551 |
| 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 | 4340 SWINNEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-03-26 |