FDA Adverse Event
Malfunction
Summary report: N
8.0MM TI MATRIX POLYAXIAL SCREW 70MM THREAD LENGTH
MDR report key: 3463487
·
Received November 12, 2013
Report
- Report Number
- 2530088-2013-01268
- Event Type
- Malfunction
- Date Received
- November 12, 2013
- Date of Event
- October 18, 2013
- Report Date
- October 21, 2013
- Manufacturer
- SYNTHES BRANDYWINE
- Product Code
- NKB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL PRODUCTS: MNH, MNI, KWQ, KWP. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. (B)(4). PLACEHOLDER.
Description of Event or Problem · 1
IT WAS REPORTED THAT ON (B)(6) 2013, THE HEADS OF TWO MATRIX SCREWS CAME OFF AS THEY WERE THREADED INTO THE PEDICLE. THE BROKEN DEVICES WERE REMOVED. SURGERY WAS DELAYED FIVE MINUTES DUE TO THE EVENT. IT WAS REPORTED THAT NO INJURY WAS CAUSED TO THE PATIENT. NEW SCREWS WERE IMPLANTED AND THE PROCEDURE WAS REPORTED AS SUCCESSFULLY COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 585566 | 8.0MM TI MATRIX POLYAXIAL SCREW 70MM THREAD LENGTH | NKB | SYNTHES BRANDYWINE | 6813430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |