FDA Adverse Event
Injury
Summary report: N
VERTEX RECONSTRUCTION SYSTEM
MDR report key: 1439830
·
Received August 11, 2009
Report
- Report Number
- 1030489-2009-00753
- Event Type
- Injury
- Date Received
- August 11, 2009
- Report Date
- July 13, 2009
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- KWQ
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. IN ADDITION, THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 6900240, WAS CLEARED IN THE UNITED STATES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WITH KYPHOSIS UNDERWENT A PROCEDURE TO FIX O/T1 USING POSTERIOR FIXATION. IT WAS REPORTED THAT RIGHT SIDE ROD WAS BROKEN AT O/C1. THE PATIENT REPORTEDLY WAS ASYMPTOMATIC. THE REVISION SURGERY WAS PERFORMED SEVEN WEEKS POST OP TO REPLACE THE ROD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERTEX RECONSTRUCTION SYSTEM | ROD | KWQ | WARSAW ORTHOPEDIC INC. | NA | 0014479W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |