MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-09 for ALGEA THERAPIES REF 658.902S.1 manufactured by Globus Medical, Inc..
[38772834]
A (b)(6) male undergoing a minimally invasive approach claudication of l4-l5 and during the use of the jamshidi needle was being used and broke off into multiple pieces. At this point the case was converted to open and fluoro was used to locate all the pieces of the fractured needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5450350 |
| MDR Report Key | 5450350 |
| Date Received | 2016-02-09 |
| Date of Report | 2016-02-09 |
| Date of Event | 2016-02-02 |
| Date Facility Aware | 2016-02-02 |
| Report Date | 2016-02-09 |
| Date Reported to FDA | 2016-02-09 |
| Date Reported to Mfgr | 2016-02-09 |
| Date Added to Maude | 2016-02-22 |
| 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 | RISK MANAGER |
| 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 | 0 |
| Brand Name | ALGEA THERAPIES |
| Generic Name | AFFIRM ACCESS PACK, ULTRA, TRAY |
| Product Code | FSH |
| Date Received | 2016-02-09 |
| Model Number | REF 658.902S.1 |
| Lot Number | LN002260 |
| Device Expiration Date | 2019-03-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | I |
| 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 | 1. Hospitalization | 2016-02-09 |