FDA Adverse Event
Malfunction
Summary report: N
PSX INTERBODY SYSTEM
MDR report key: 14068486
·
Received April 9, 2022
Report
- Report Number
- 2027467-2022-00014
- Event Type
- Malfunction
- Date Received
- April 9, 2022
- Date of Event
- March 10, 2022
- Report Date
- March 10, 2022
- Manufacturer
- ALPHATEC SPINE, INC.
- Product Code
- MAX
- UDI-DI
- 00190376396798
- PMA / PMN Number
- K211873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE IMPLANT HAS NOT BEEN RETURNED FOR EVALUATION. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF MANUFACTURING RECORDS CANNOT BE PERFORMED. THE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
DURING SURGERY, A PSX LORDOTIC EXPANDABLE, 8 X 10 X 30MM, 20° BROKE WHILE THE SURGEON WAS TRYING TO ACHIEVE MORE LORDOSIS. A BILATERAL CAGE WAS PLACED IN THE DISC SPACE ON THE PATIENT'S RIGHT SIDE IN AN ATTEMPT TO ALLEVIATE THE INITIAL BROKEN CAGE FROM COLLAPSING AND/OR MIGRATING. THIS CAUSED A DELAY IN SURGERY. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1110546 | PSX INTERBODY SYSTEM | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR | MAX | ALPHATEC SPINE, INC. | 320-08103000 | 00190376396798 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |