FDA Adverse Event
Injury
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 1982313
·
Received February 9, 2011
Report
- Report Number
- 1030489-2011-00106
- Event Type
- Injury
- Date Received
- February 9, 2011
- Date of Event
- January 10, 2011
- Report Date
- January 11, 2011
- Manufacturer
- WARSAW ORTHOPEDIC, INC.
- Product Code
- KWP
- PMA / PMN Number
- K052187
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT 10 DAYS POST-OP THE SET SCREW DISASSOCIATED FROM THE PEDICLE SCREW AFTER THE PATIENT FELL. THE PATIENT UNDERWENT A REVISION SURGERY 20 DAYS POST-OP; THE SET SCREW WAS REPLACED SUCCESSFULLY. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | WARSAW ORTHOPEDIC, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | BONE SCREW |