BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 35 MM

    MDR report key: 6296255 · Received February 2, 2017

    Report

    Report Number
    3005525032-2017-00015
    Event Type
    Injury
    Date Received
    February 2, 2017
    Date of Event
    January 6, 2017
    Report Date
    May 30, 2017
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    MNH
    UDI-DI
    04546540562227
    PMA / PMN Number
    K071373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RISK ASSESSMENT; VISUAL, DIMENSIONAL AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED AND LOT# WAS NOT PROVIDED. THE DEFINITIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM GIVEN INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT THE SURGERY WITH FOR TH10-L1(PLF). ON (B)(6) 2016, THE PATIENT UNDERWENT THE REVISION SURGERY FOR L2-3(PLIF). AFTER SURGERY, WHEN THE SURGEON CHECKED X-RAY, THE SCREW BROKE. THEREFORE, THE SURGEON PLANNING THE REVISION SURGERY NOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT THE SURGERY WITH FOR TH10-L1(PLF). ON (B)(6) 2016, THE PATIENT UNDERWENT THE REVISION SURGERY FOR L2-3(PLIF). AFTER SURGERY, WHEN THE SURGEON CHECKED X-RAY, THE SCREW BROKE. THEREFORE, THE SURGEON PLANNING THE REVISION SURGERY NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80226 XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 35 MM PEDICLE SCREW SPINAL SYSTEM. MNH STRYKER SPINE-SWITZERLAND UNKNOWN 04546540562227

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention