BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN

    MDR report key: 3525109 · Received December 18, 2013

    Report

    Report Number
    2520274-2013-07596
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    November 22, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADD'L PRO CODES: MNH, MNI, KWO, KWP. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHILE ATTEMPTING TO REMOVE TWO MATRIX SCREWS AT THE LOWER END OF THE CONSTRUCTION, THE LOCKING CAPS COULD NOT BE OPENED. TWO DIFFERENT SCREWDRIVERS WITH T-HANDLES WERE USED AND WERE DAMAGED. ONE SCREWDRIVER WAS DAMAGED AT THE TOP OF THE SHAFT AND THE OTHER WHERE THE HANDLE CONNECTS TO THE SHAFT. THE SCREWS WERE EVENTUALLY REMOVED AFTER CUTTING THE ROD WITH A DRILL. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663392 LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1