MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-08 for K-WIRE 685-007 manufactured by Globus Medical, Inc..
[96615333]
Patient Sequence No: 1, Text Type: N, H10
[96615334]
During l4-5 spondylolisthesis and radiculopathy, following placement of l5 pedicle screw, the k-wire did not advance. The tip then bent. Upon removing the pedicle screw partially, we noted that the k-wire tip had broken off in the vertebral body. The k-wire was replaced here and then the jamshidi needle was removed. We tapped the trajectory and tried placing the pedicle screws here again and again. The same issue occurred where the head of the l4 pedicle screw interfered with the trajectory and caused bending of the k-wire before full advancement of the pedicle screw. We then removed the pedicle screw again over the k-wire, and again noted that the k-wire tip had broken within the vertebral body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7171302 |
| MDR Report Key | 7171302 |
| Date Received | 2018-01-08 |
| Date of Report | 2017-12-22 |
| Date of Event | 2017-12-11 |
| Report Date | 2017-12-19 |
| Date Reported to FDA | 2017-12-19 |
| Date Reported to Mfgr | 2017-12-19 |
| Date Added to Maude | 2018-01-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | K-WIRE |
| Generic Name | WIRE, FIXATION, INTRAOSSEOUS |
| Product Code | DZK |
| Date Received | 2018-01-08 |
| Catalog Number | 685-007 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLOBUS MEDICAL, INC. |
| Manufacturer Address | 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER AUDUBON PA 19403 US 19403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-08 |