BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S4 POLYAXIAL SCREW 6.0X40MM

    MDR report key: 4080788 · Received August 27, 2014

    Report

    Report Number
    2916714-2014-00688
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    April 29, 2014
    Report Date
    August 27, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    KWP
    PMA / PMN Number
    K033219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON: (B)(4) 2014. MFG SITE EVAL: RECEIVED TWO POLYAXIAL SCREWS AND SIX SET SCREWS. THIS POLYAXIAL SCREW BELONGS TO AN OLD VERSION. THE PROBLEM WITH THE LOOSENING INSERT WAS A KNOWN PROBLEM IN THE PAST, THEREFORE, THE INSERT HAS BEEN CHANGED. HOWEVER, THE INSERT EXHIBITS VISIBLE DEFORMATIONS AND SCRATCH MARKS, DUE TO THE LACK OF INFO AND PROBLEMS WITH THE CLASSIFICATION OF THE SEVERAL COMPONENTS, AN INVESTIGATION IS ONLY PARTLY POSSIBLE. IT APPEARS AS IF THE INSERT RELEASED DUE TO THE SCREWDRIVER APPLYING FORCE TO THE INSERT. THE MFG DOCUMENTATION HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO OEM SPECIFICATION AT THE TIME OF PRODUCTION. INVESTIGATION DETERMINED THE FAILURE TO MOST LIKELY BE USER RELATED.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). COMPLAINT STATES: THE BODY OF THE SCREW CAME OUT FROM THE SCREW HEAD DURING THE INSERTION PROCEDURE, SO THE SURGEON COULD NOT PLACE THE RODS INTO THE SCREW HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518731 S4 POLYAXIAL SCREW 6.0X40MM POSTERIOR IMPLANT KWP AESCULAP AG & CO. KG SW774T 51756091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other