1030489-2018-01098
Report
- Report Number
- 1030489-2018-01098
- Event Type
- Injury
- Date Received
- August 7, 2018
- Report Date
- December 21, 2018
- PMA / PMN Number
- SEE H10
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 5440030, 510K # K102555 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT ANALYSIS: VISUAL AND MICROSCOPIC EVALUATION SHOWED THAT THERE IS DAMAGE TO ONE SIDE OF THE SCREW WHERE IT APPEARS IT DISENGAGED FROM THE BONE SCREW HEAD AND WAS MOVING INSIDE THE BONE SCREW HEAD. THERE IS A WITNESS MARK ON THE FACE OF THE SCREW WHERE THE ROD WAS MOVING INSIDE THE BONE SCREW HEAD. THIS WITNESS MARKS IS ANGLED TO THE OPPOSITE SIDE TO THE THREAD DAMAGED INDICATING ROD ANGULATION. THE DAMAGE TO THE SET SCREW APPEARS TO BE THE RESULT OF THE ROD FAILURE(NOT RETURNED) NOT THE CAUSE OF THE FAILURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
TYPE OF PROCEDURE (INITIAL SURGERY): TH9-S2AI FIXATION LEVELS IMPLANTED: TH9-S2AI IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE SET SCREW OF L4 SCREW ON THE CAUDAL SIDE OF THE ROD LOOSENED, AND THE SCREW HEAD WAS MOVING. THREADS OF THE SET SCREW WERE NOTED TO BE DAMAGED. THE PATIENT ALSO EXPERIENCED PAIN. HENCE, ON (B)(6) 2018, THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THE LOOSENED SET SCREW WAS REPLACED WITH A NEW ONE.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |