FDA Adverse Event
Injury
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 7288262
·
Received February 22, 2018
Report
- Report Number
- 1030489-2018-00260
- Event Type
- Injury
- Date Received
- February 22, 2018
- Report Date
- February 22, 2018
- Manufacturer
- WARSAW ORTHOPEDICS
- Product Code
- NKB
- PMA / PMN Number
- SEE H10
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 1556200500, 510K# K131321 AND UDI (B)(4) IS APPROVED FOR SALE IN US. : NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. 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 POSTERIOR FUSION AT T8-S2AI DUE TO LOWER BACK ACHE AND PALSY OCCURRENCE. POST-OP, THE IMPLANTED ROD BROKE AT THE LEFT SIDE OF L4/5. PATIENT UNDERWENT REVISION SURGERY FOR REPLACING THE BROKEN ROD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 132576 | 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 |