FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 3173729
·
Received June 17, 2013
Report
- Report Number
- 1030489-2013-02335
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Date of Event
- May 19, 2013
- Report Date
- May 19, 2013
- Manufacturer
- WARSAW ORTHOPEDICS
- Product Code
- NKB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6). (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L3-L5. IT WAS REPORTED THAT THIS SURGERY IS A REVISION SURGERY OF L4-L5 TLIF. IT WAS REPORTED THAT THE MIDLINE NUT OF THE CROSSLINK BROKE DURING FINAL TIGHTENING. THE CROSSLINK WAS PLACED BETWEEN L3 AND L4 LEVEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273831 | CD HORIZON SPINAL SYSTEM | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE | NKB | WARSAW ORTHOPEDICS | NA | 0242096W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00065 YR |