FDA Adverse Event
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 3893755
·
Received June 25, 2014
Report
- Report Number
- 1030489-2014-02889
- Date Received
- June 25, 2014
- Date of Event
- May 27, 2014
- Report Date
- May 27, 2014
- 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). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 1604200500, 510K # K113174 WAS CLEARED IN THE UNITED STATES. 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 POSTERIOR SPINAL SURGICAL PROCEDURE AT T10-ILIAC TO TREAT DEGENERATIVE SCOLIOSIS. IT WAS REPORTED THAT AT THE TIME OF CONTOURING THE ROD THE SURFACE COATING CAME OFF IN LAYERS WITHIN THE OPERATIVE FIELD. FRAGMENTS WERE LEFT IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370665 | CD HORIZON SPINAL SYSTEM | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE | NKB | WARSAW ORTHOPEDICS | NA | 0240257W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | SCREWS, SET SCREWS |