MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for CREO 5119.1652 manufactured by Globus Medical, Inc..
[177803963]
The patient had a l5-s1 fusion and decompression for left leg radiculopathy without complications. While at home in bed 3 days later the patient jolted from sleep due to a loud noise and twisted suddenly. He felt a pop in his back and since then he has felt some popping in his back but no pain down his legs. X-rays showed what appears to be failure of the pedicle screw-rod-set screw junction on the left side at l5. The pedicle screws appear appropriately placed and there is fusion material in the paraspinal gutter, but the set screw appears to no longer be over the left rod at the l5 pedicle. This was compared to the intraoperative films and clearly the rods were long enough, and the set screws appeared engaged. Approximately 3 weeks later, the hardware was removed and replaced. The patient is recovering without any consequences. The surgeon has never had this happen before. He always checks his equipment prior to implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9670929 |
| MDR Report Key | 9670929 |
| Date Received | 2020-02-05 |
| Date of Report | 2019-10-09 |
| Date of Event | 2019-09-23 |
| Report Date | 2019-12-12 |
| Date Reported to FDA | 2019-12-12 |
| Date Reported to Mfgr | 2020-02-05 |
| Date Added to Maude | 2020-02-05 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CREO |
| Generic Name | ORTHOSIS, SPINAL PEDICLE FIXATION |
| Product Code | MNI |
| Date Received | 2020-02-05 |
| Model Number | 5119.1652 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLOBUS MEDICAL, INC. |
| Manufacturer Address | 2560 GENERAL ARMISTEAD AVENUE AUDOBON PA 19403 US 19403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |