MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-05 for KMEDIC NERVE HOOK KM55-664 manufactured by Teleflex Medical.
[61415729]
Patient Sequence No: 1, Text Type: N, H10
[61415730]
During an anterior lumbar interbody fusion (alif) procedure, one of the spine usa nerve hooks broke. The surgeon was able to retrieve all pieces. A post-operative x-ray was negative for retained foreign bodies.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6144341 |
| MDR Report Key | 6144341 |
| Date Received | 2016-12-05 |
| Date of Report | 2016-12-02 |
| Date of Event | 2016-11-14 |
| Report Date | 2016-11-15 |
| Date Reported to FDA | 2016-11-15 |
| Date Reported to Mfgr | 2016-11-15 |
| Date Added to Maude | 2016-12-05 |
| 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 | KMEDIC NERVE HOOK |
| Generic Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Product Code | GDG |
| Date Received | 2016-12-05 |
| Catalog Number | KM55-664 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | 3015 CARRINGTON MILL BLVD. MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-05 |