MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-17 for SCREWS manufactured by Amendia, Inc..
[38308894]
Patient Sequence No: 1, Text Type: N, H10
[38308895]
A female patient was admitted early this year with complaints of lower left leg pain and lower back pain. The patient had a previous l4-s1 fusion. The work up revealed bilateral broken screws at s1 and the cage migrated in the canal with severe foraminal stenosis. The patient was taken to surgery for revision and removal and replacement of the screws. The patient did well postoperatively and was discharged a few days later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5440756 |
| MDR Report Key | 5440756 |
| Date Received | 2016-02-17 |
| Date of Report | 2016-02-09 |
| Date of Event | 2016-01-22 |
| Report Date | 2016-02-09 |
| Date Reported to FDA | 2016-02-09 |
| Date Reported to Mfgr | 2016-02-09 |
| Date Added to Maude | 2016-02-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCREWS |
| Generic Name | SYSTEM, FACET SCREW SPINAL DEVICE |
| Product Code | MRW |
| Date Received | 2016-02-17 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMENDIA, INC. |
| Manufacturer Address | 1755 W. OAK PKWY SUITE 100 MARIETTA GA 30062 US 30062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-17 |