FDA Adverse Event
Injury
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 8964366
·
Received September 5, 2019
Report
- Report Number
- 1030489-2019-00979
- Event Type
- Injury
- Date Received
- September 5, 2019
- Date of Event
- August 7, 2019
- Report Date
- September 5, 2019
- Manufacturer
- WARSAW ORTHOPEDICS
- Product Code
- KWP
- 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 PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 1606200500, 510K # K131321; UDI# (B)(4) WAS CLEARED IN THE UNITED STATES. 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. 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 SPINAL FUSION SURGERY AT T10-S2 DUE TO UNKNOWN REASON. POST-OP, ROD BROKE NEAR L3/4. A REVISION SURGERY WAS PERFORMED IN WHICH ROD WAS REMOVED AND F5.5 COBALT CHROME ROD WAS NEWLY PLACED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 759756 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | WARSAW ORTHOPEDICS | NA | 0628038W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |