XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 50 MM
Report
- Report Number
- 3005525032-2016-00028
- Event Type
- Injury
- Date Received
- March 29, 2016
- Date of Event
- March 1, 2016
- Report Date
- March 3, 2016
- Manufacturer
- STRYKER SPINE-SWITZERLAND
- Product Code
- MNH
- PMA / PMN Number
- K071373
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
METHOD: RISK ASSESMENT. RESULT: THE CUSTOMER REPORTED EVENT WAS CONFIRMED VIA CORRESPONDENCE WITH THE STRYKER REPRESENTATIVE. NO LOT # WAS PROVIDED, SO A MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE ROOT CAUSE COULD NOT BE DETERMINED, AS THE DEVICE WAS NOT RETURNED AND INSUFFICIENT INFORMATION WAS RECEIVED TO DETERMINE A PLAUSIBLE ROOT CAUSE.
IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT UNDERWENT THE SURGERY FOR SPINAL CANAL STENOSIS. AFTER THE SURGERY, THE SURGEON CONFIRMED X-RAY AND FOUND THAT PJK AND T11 SCREWS WERE LOOSENING. THE SURGEON WAS PLANNING REVISION SURGERY ON (B)(6) 2016. HOWEVER, NUMBNESS OCCURRED TO THE PATIENT, SO HE UNDERWENT AN URGENT OPERATION IN (B)(6) 2016. THE SURGEON CHANGED ALL SCREWS OF T11-L4. AND ADDED FIXED T4-L4. T4-T9 WAS DISH.
IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT UNDERWENT THE SURGERY FOR SPINAL CANAL STENOSIS. AFTER THE SURGERY, THE SURGEON CONFIRMED X-RAY AND FOUND THAT PJK AND T11 SCREWS WERE LOOSENING. THE SURGEON WAS PLANNING REVISION SURGERY ON (B)(6) 2016. HOWEVER, NUMBNESS OCCURRED TO THE PATIENT, SO HE UNDERWENT AN URGENT OPERATION IN (B)(6) 2016. THE SURGEON CHANGED ALL SCREWS OF T11-L4. AND ADDED FIXED T4-L4. T4-T9 WAS DISH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 189159 | XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 50 MM | PEDICLE SCREW SPINAL SYSTEM. | MNH | STRYKER SPINE-SWITZERLAND | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |