BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABC SE;F-LOCKING CERVICAL SCREW 4.0X16MM

    MDR report key: 4688840 · Received April 10, 2015

    Report

    Report Number
    3005673311-2015-00034
    Event Type
    Malfunction
    Date Received
    April 10, 2015
    Report Date
    April 7, 2015
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    KWQ
    PMA / PMN Number
    K050813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2015. INVESTIGATION OF THE SCREW SHOWED THE LOCKING PIN SITS ABOVE THE SCREW HEAD INSTEAD OF FLUSH WITH IT. MICROSCOPIC ANALYSIS SHOWED THE CANNULATED THREAD OF THE LOCKING PIN CONTAINS THE TIP OF AN INSTRUMENT. IT IS ASSUMED THAT THE TIP IS FROM THE RESCUE DEVICE (FJ911R). THE HEXAGON OF THE LOCKING PIN AND THE HEXAGON INSIDE THE SCREW SHOW VISIBLE DAMAGE. IT APPEARS THAT HIGH FORCES WERE APPLIED. DEVICE HISTORY AND MANUFACTURING DOCUMENTS WERE REVIEWED. ALL RECORDS COMPLY WITH SPECIFICATION AND DO NOT REPRESENT ANY DEVIATIONS. THERE ARE NO OTHER COMPLAINTS REGARDING THIS BATCH. ROOT CAUSE FOR THE FAILURE HAS BEEN DETERMINED TO BE USER RELATED. IT APPEARS THAT HIGH FORCES WERE APPLIED WITH THE SCREW DRIVER (FJ910R) AND THE RESCUE INSTRUMENT (FJ911R). THIS LED TO AN OUTWARD BENDING OF THE SCREW HEAD SEGMENTS (PETALS). WITH THE BENT PETALS, THE LOCKING PIN WAS ABLE TO BE UNLOCKED. MATERIAL OR MANUFACTURING FAILURE HAS BEEN EXCLUDED.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(4). DURING SCREW INSERTION THE INLAY FELL OUT. THEREFORE, THE SCREW HAD TO BE EXCHANGED. THE NEW SCREW HAD TO BE FIXED WITH A BIT OF CEMENT. NO PT HARM/INJURY. OPERATION TIME DELAY ABOUT 10 MINS. OPERATION COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238145 ABC SE;F-LOCKING CERVICAL SCREW 4.0X16MM BONE SCREW KWQ AESCULAP AG & CO. KG FJ933T 52049598

    Patients

    Seq Age Sex Outcome Treatment
    1