BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM BLOCKER

    MDR report key: 5382701 · Received January 21, 2016

    Report

    Report Number
    3004024955-2016-00007
    Event Type
    Malfunction
    Date Received
    January 21, 2016
    Date of Event
    December 29, 2015
    Report Date
    December 29, 2015
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    MNI
    PMA / PMN Number
    K071373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT# Z9N. DATE OF EXPLANT: (B)(6) 2016. PMA/510(K)#: K071373. METHOD: VISUAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: MANUFACTURING RECORDS WERE REVIEWED FOR THE CORRESPONDING LOT AND NO RELEVANT ISSUES WERE IDENTIFIED. INSPECTION OF THE BLOCKER REVEALED NO DEFORMATION AND INDENTATION OF ITS BASE. THIS SUGGESTS THAT THE BLOCKERS DID NOT EXPERIENCE A SUFFICIENT TIGHTENING TORQUE. CONCLUSION: THE MOST LIKELY CAUSE OF THE CUSTOMER REPORTED EVENT IS AN INSUFFICIENT TIGHTENING TORQUE DURING FINAL TIGHTENING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLOCKER CAME OFF FROM THE SCREW. THE REVISION SURGERY IS PLANNED ON (B)(6) 2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLOCKER CAME OFF FROM THE SCREW. THE REVISION SURGERY IS PLANNED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40972 XIA 3 TITANIUM BLOCKER PEDICLE SCREW SPINAL SYSTEM MNI STRYKER SPINE-SWITZERLAND

    Patients

    Seq Age Sex Outcome Treatment
    1