BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUINTEX SEMICONSTRAINED SCREW 4.0X16MM

    MDR report key: 3908049 · Received March 6, 2014

    Report

    Report Number
    3005673311-2014-00004
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    November 29, 2013
    Report Date
    January 2, 2014
    Manufacturer
    AESCULAP AG AND CO. KG
    Product Code
    LWJ
    PMA / PMN Number
    K071916
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): K081973. US REPORTED AGENT NOTIFIED ON (B)(4)2013. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). REVISION SURGERY DUE TO MEDICAL CONDITION OF THE PT (NOT SPECIFIED); HIP COMPLAINTS. NO FRACTURE OF THE CONE, BUT SIGNS FOR CORROSION SUSPECTED BY CUSTOMER. REVISION SURGERY DUE TO HIP COMPLAINTS. CUP AND INLAY WERE NOT EXPLANTED BECAUSE THEY FIT WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136990 QUINTEX SEMICONSTRAINED SCREW 4.0X16MM LWJ AESCULAP AG AND CO. KG NC078K 51664577

    Patients

    Seq Age Sex Outcome Treatment
    1 Other