BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA TITANIUM 4.5 BLOCKER

    MDR report key: 10489733 · Received September 3, 2020

    Report

    Report Number
    0009617544-2020-00153
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    August 7, 2020
    Report Date
    December 17, 2020
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKB
    PMA / PMN Number
    K121342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO G4 FROM 'K142381' TO 'K121342'. RECEIVED ADDITIONAL DEVICE INFORMATION.

    Additional Manufacturer Narrative · 0

    VISUAL, DIMENSIONAL, FUNCTIONAL AND MATERIAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. DEVICE AND COMPLAINT HISTORY RECORDS WERE REVIEWED FOR THIS LOT, AND NO RELEVANT MANUFACTURING ISSUES OR SIMILAR COMPLAINTS WERE IDENTIFIED. PER XIA 4.5 SURGICAL TECHNIQUE: THE BLOCKER IS INSERTED WITH THE 4MM BLOCKER INSERTER, SHORT WHEN THE ROD IS FULLY SEATED INTO THE HEAD OF THE IMPLANT. NOTE: 4MM BLOCKER INSERTER, SHORT IS NOT TO BE USED FOR FINAL TIGHTENING. ONCE THE CORRECTION PROCEDURES HAVE BEEN CARRIED OUT AND THE SPINE IS FIXED IN A SATISFACTORY POSITION, THE FINAL TIGHTENING OF THE BLOCKERS IS DONE BY UTILIZING THE ANTI-TORQUE KEY AND THE TORQUE WRENCH. THE TORQUE WRENCH INDICATES THE APPROPRIATE TORQUE THAT HAS TO BE APPLIED TO THE IMPLANT FOR FINAL TIGHTENING. LINE UP THE ARROW TO THE LINE IN ORDER TO ACHIEVE THIS FINAL TIGHTENING TORQUE OF 8 NM. SINCE THE DEVICE WAS NOT RETURNED, AN EXACT CAUSE CANNOT BE ESTABLISHED. BUT PROBABLE CAUSE INCLUDE: CROSS THREADING DURING BLOCKER INSERTION OR FINAL TIGHTENING. H3 OTHER TEXT : DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING FINAL TIGHTENING A XIA 4.5 BLOCKER CROSSED THREADED AND WAS UNABLE TO BE FULLY TIGHTENED. THE BLOCKER WAS LEFT IN THE PATIENT IN THIS STATE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED BUT AN UNSPECIFIED SURGICAL DELAY DID OCCUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING FINAL TIGHTENING A XIA 4.5 BLOCKER CROSSED THREADED AND WAS UNABLE TO BE FULLY TIGHTENED. THE BLOCKER WAS LEFT IN THE PATIENT IN THIS STATE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FINAL TIGHTENING AN UNKNOWN XIA BLOCKER CROSSED THREADED AND WAS UNABLE TO BE FULLY TIGHTENED. THE BLOCKER WAS LEFT IN THE PATIENT IN THIS STATE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED BUT AN UNSPECIFIED SURGICAL DELAY DID OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955717 XIA TITANIUM 4.5 BLOCKER THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB STRYKER SPINE-US

    Patients

    Seq Age Sex Outcome Treatment
    1