BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSITION-INSTR F/POLYAXIAL SCREW HEADS F

    MDR report key: 3133026 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02892
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    March 1, 2013
    Report Date
    May 4, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING SURGERY ON (B)(6) 2013, THE POLYAXIAL HEAD PLACEMENT TOOL WAS IDENTIFIED AS DAMAGED. WHILE TRYING TO CLICK THE 3-D HEADS ONTO THE SCREWS WITH THE TOOL, THE HEADS REPEATEDLY CLICKED OFF AS THE SLEEVE IN THE 3-D HEADS KEPT LOCKING UP. THE SLEEVE WAS PUSHED DOWN AND THEN THE HEADS WERE CAREFULLY CLICKED ONTO THE SCREWS, WHILE TAKING CARE NOT TO USE ENOUGH FORCE TO LOCKOUT THE SLEEVE. THIS WAS SUCCESSFUL BUT FRUSTRATING TO THE SURGEON. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235192 POSITION-INSTR F/POLYAXIAL SCREW HEADS F LXH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1