FDA Adverse Event
Injury
Summary report: N
CD HORIZON® SPINAL SYSTEM
MDR report key: 2011527
·
Received March 9, 2011
Report
- Report Number
- 1030489-2011-00259
- Event Type
- Injury
- Date Received
- March 9, 2011
- Report Date
- February 8, 2011
- Manufacturer
- WARSAW ORTHOPEDIC, INC.
- Product Code
- KWP
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 MULTI-LEVEL SPINAL FUSION WITH VERTEBRAL BODY REPLACEMENTS AT L4-L5. IT WAS REPORTED THAT THE PATIENT HAD SCREWS BREAK BILATERALLY AT S1. THE PATIENT REPORTED HAVING BACK PAIN AND LEG PAIN. NO REVISION SURGERY HAS BEEN SCHEDULED YET. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON® SPINAL SYSTEM | KWP | WARSAW ORTHOPEDIC, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |