FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 1021661
·
Received March 18, 2008
Report
- Report Number
- 1030489-2008-00139
- Event Type
- Malfunction
- Date Received
- March 18, 2008
- Date of Event
- February 18, 2008
- Report Date
- February 18, 2008
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- KWP
- PMA / PMN Number
- K052187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO MEDTRONIC FOR EVAL. UNABLE TO DETERMINE CAUSE OF THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON COULD NOT BREAK OFF THE TAB OF THE BREAK-OFF SETSCREW. AFTER SEVERAL ATTEMPTS, THE SURGEON DECIDED TO TIGHTEN THE SETSCREW AS MUCH AS POSSIBLE AND LEAVE IT IMPLANTED WITH THE TAB INTACT. NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON SPINAL SYSTEM | SETSCREW | KWP | WARSAW ORTHOPEDIC INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |