FDA Adverse Event
Injury
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 6566153
·
Received May 15, 2017
Report
- Report Number
- 1030489-2017-01220
- Event Type
- Injury
- Date Received
- May 15, 2017
- Report Date
- April 17, 2017
- Manufacturer
- WARSAW ORTHOPEDICS
- Product Code
- NKB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 1476000500, 510K # K091974 WAS CLEARED IN THE UNITED STATES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR THORACOLUMBAR FUSION SURGERY DUE TO POSTERIOR FUSION FOR METASTATIC TUMOR IN WHICH RODS WERE IMPLANTED. POSTOPERATIVELY IT WAS REPORTED THAT ON UNKNOWN DATE THE ROD BREAKAGE WAS OBSERVED. THE PATIENT IS SCHEDULED TO UNDERGO A 4 ROD PROCEDURE REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 347687 | CD HORIZON SPINAL SYSTEM | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE | NKB | WARSAW ORTHOPEDICS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |