BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM

    MDR report key: 2922815 · Received January 18, 2013

    Report

    Report Number
    2530088-2013-00051
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    November 21, 2012
    Report Date
    December 20, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE FIRST PRIMELOCK THREAD OF THE BONE SCREW IS BROKEN AWAY ON 50 PERCENT OF THE CIRCUMFERENCE. THE SCREW HEAD IS THE LATEST GENERATION WITH UPDATED COLLET/SCREW HEAD INTERFACE. POSSIBLE CAUSE FOR THE RELEASE OF THE SCREW HEAD FROM THE BONE SCREW IS THE DAMAGE OF THE RIM OF THE BONE SCREW. AN INTACT SPHERICAL HEAD OF THE BONE SCREW IS IMPORTANT FOR CORRECT RETENTION OF THE SCREW HEAD. POSSIBLY THE TIP OF THE RETAINING SLEEVE WAS NOT SUFFICIENTLY TIGHTENED INTO THE PRIMELOCK THREAD OF THE BONE SCREW. ALTERNATIVELY IT IS POSSIBLE, THAT THE PRIMELOCK CONNECTION BETWEEN RETAINING SLEEVE AND BONE SCREW WAS INADVERTENTLY LOOSENED BY GRASPING THE GREEN KNOB DURING SCREW INSERTION. BOTH POSSIBILITIES LEAD TO INSUFFICIENT ENGAGEMENT OF THE THREAD FLANKS IN THE PRIMELOCK THREAD OF THE BONE SCREW. IN COMBINATION WITH HIGH LATERAL FORCES, BY EXCESSIVE CORRECTION OF SCREW TRAJECTORY, SOFT TISSUE PUSH OR STRONG DISTRACTION FORCES, IT CAN LEAD TO OVERLOAD AND BREAKING OF REMAINING ENGAGED THREAD FLANKS. REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT DURING AS PROCEDURE, AS THE SURGEON WAS INSERTING THE SCREW INTO THE SACRUM, THE HEAD DROPPED. THE SURGEON WAS ABLE TO REMOVE THE SCREW AND USED ANOTHER OF THE SAME SIZE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27819 PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM SCREW NKB SYNTHES BRANDYWINE 8018907

    Patients

    Seq Age Sex Outcome Treatment
    1