FDA Adverse Event
Malfunction
Summary report: N
PSX INTERBODY SYSTEM
MDR report key: 15591081
·
Received October 12, 2022
Report
- Report Number
- 2027467-2022-00070
- Event Type
- Malfunction
- Date Received
- October 12, 2022
- Date of Event
- September 13, 2022
- Report Date
- September 13, 2022
- Manufacturer
- ALPHATEC SPINE, INC
- Product Code
- MAX
- PMA / PMN Number
- K211873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
NO DEVICE EVALUATION POSSIBLE AS IMPLANT REMAINS IN-SITU. A RADIOGRAPH WAS PROVIDED TO CONFIRM THE EVENT. NEITHER THE PART NOR LOT NUMBERS WERE PROVIDED. BASED ON THE INFORMATION PROVIDED, A ROOT CAUSE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED A PSX CAGE COLLAPSED POSTOPERATIVELY AT L5-S1. THE PATIENT IS ASYMPTOMATIC. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT. THERE NO PLANS FOR ADDITIONAL SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2804897 | PSX INTERBODY SYSTEM | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR | MAX | ALPHATEC SPINE, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |