FDA Adverse Event
Malfunction
Summary report: N
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
MDR report key: 4152015
·
Received October 8, 2014
Report
- Report Number
- 1030489-2014-03920
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- September 25, 2014
- Report Date
- September 25, 2014
- Manufacturer
- WARSAW ORTHOPEDIC, INC.
- Product Code
- KWP
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN L4/L5 ARTHRODESIS PLIF PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE JAW OF THE CROSSLINK BROKE UPON INSERTION. THE BROKEN PIECES WERE REMOVED AND THE PROCEDURE COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632631 | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | WARSAW ORTHOPEDIC, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR |