BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEIGHT EXPANSION DRIVER

    MDR report key: 12987746 · Received December 13, 2021

    Report

    Report Number
    3004774118-2021-00390
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    November 29, 2021
    Report Date
    April 1, 2022
    Manufacturer
    K2M, INC.
    Product Code
    MPQ
    UDI-DI
    10888857033641
    PMA / PMN Number
    K142016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: THE TIP OF THE DRIVER WAS DEFORMED AND STRIPPED. DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS LOT AND NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. COMPLAINT HISTORY RECORDS WERE REVIEWED FOR THIS LOT, SIMILAR COMPLAINTS WERE IDENTIFIED. FROM THE CAPRI SURGICAL TECHNIQUE GUIDE: THE LIFE OF THE INSTRUMENT DEPENDS ON THE NUMBER OF TIMES THEY ARE USED AS WELL AS THE PRECAUTIONS TAKEN IN HANDLING, CLEANING AND STORAGE. GREAT CARE MUST BE TAKEN OF THE INSTRUMENTS TO ENSURE THAT THEY REMAIN IN GOOD WORKING ORDER. INSTRUMENTS SHOULD BE EXAMINED FOR WEAR OR DAMAGE BY DOCTORS AND STAFF IN OPERATING CENTERS PRIOR TO SURGERY AS THE DEVICE IS FIVE YEARS OLD, WEAR FROM ITS EXTENDED USE IS THE LIKELY CAUSE FOR THE EVENT. MISALIGNMENT WITH THE MATING SCREW AND/OR EXCESSIVE FORCE APPLIED MAY ALSO CAUSE THE TIP TO DEFORM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CAPRI EXPANDABLE HEIGHT EXPANSION DRIVER "NO LONGER GRIPS THE SCREW HEAD" AFTER CLEANING/STERILIZATION. THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CAPRI EXPANDABLE HEIGHT EXPANSION DRIVER "NO LONGER GRIPS THE SCREW HEAD" AFTER CLEANING/STERILIZATION. THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879950 HEIGHT EXPANSION DRIVER SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MPQ K2M, INC. 2112-90007 ELDG 10888857033641

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown