FDA Adverse Event
Malfunction
Summary report: N
LIFE SPINE
MDR report key: 7234508
·
Received February 1, 2018
Report
- Report Number
- 3004499989-2018-00001
- Event Type
- Malfunction
- Date Received
- February 1, 2018
- Date of Event
- December 13, 2017
- Report Date
- January 17, 2018
- Manufacturer
- LIFE SPINE
- Product Code
- MAX
- PMA / PMN Number
- K111569
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BASED ON THE INPUT OF THE COMPLAINT THE DEVICE WAS ROTATED AFTER INSERTION, THE DEVICE COULDN'T ROTATE DUE TO EXCESSIVE RESISTANCE WITHIN DISC SPACE. THIS CAUSED TORSIONAL FORCES ON THE DEVICE THAT EXCEEDED THE STRENGTH OF THE MATERIAL WHICH CAUSED DEFORMATION OF THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A 12X28, 7 DEGREE 14MM PEEK CAGE WHEN INSERTED BROKE DURING ROTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 77290 | LIFE SPINE | PLATEAU-V | MAX | LIFE SPINE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |