FDA Adverse Event
Malfunction
Summary report: N
GLOBUS MEDICAL INC. POSTERIOR SPINAL FUSION
MDR report key: 12576323
·
Received October 4, 2021
Report
- Report Number
- MW5104376
- Event Type
- Malfunction
- Date Received
- October 4, 2021
- Report Date
- September 30, 2021
- Manufacturer
- GLOBUS MEDICAL INC.
- Product Code
- NQP
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- NO INFORMATION
Narratives
Description of Event or Problem · 1
PATIENT HAD POSTERIOR SPINAL FUSION (PSF) 5 YEARS AGO, AND NOW BACK WITH BACK PAIN. PAIN ASSESSMENT AND IMAGING HIGHLIGHTED FAILURE OF SET SCREWS FROM GLOBUS AT L2. THE SET SCREWS ARE UNSCREWING AND THE RODS ARE COMING OUT OF THE DISTAL TULIPS CAUSING PAIN AT THE DISTAL END OF HIS CONSTRUCT. FDA SAFETY REPORT ID# (B)(4). .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1464346 | GLOBUS MEDICAL INC. POSTERIOR SPINAL FUSION | POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION | NQP | GLOBUS MEDICAL INC. | 36072 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Other |