FDA Adverse Event
Injury
Summary report: N
CD HORIZON® SPINAL SYSTEM
MDR report key: 4152877
·
Received October 8, 2014
Report
- Report Number
- 1030489-2014-03930
- Event Type
- Injury
- Date Received
- October 8, 2014
- Date of Event
- September 24, 2014
- Report Date
- October 1, 2014
- Manufacturer
- WARSAW ORTHOPEDIC, INC.
- Product Code
- KWP
- PMA / PMN Number
- K981676
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- PHYSICIAN
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 UNKNOWN SPINAL PROCEDURE. AT AN UNKNOWN TIME POST-OP, IT WAS REPORTED THAT TWO RODS WERE BROKEN. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE BROKEN RODS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 630947 | CD HORIZON® SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | WARSAW ORTHOPEDIC, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00058 YR | Other |