BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL SPACER HANDLE

    MDR report key: 2873943 · Received December 14, 2012

    Report

    Report Number
    8030965-2012-01577
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRESENT HOLDER WAS CHECKED FOR CONFORMANCE TO PRINT SPECIFICATIONS, AS WELL AS THE DEVICE HISTORY RECORDS WERE RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. THE FURTHER INVESTIGATION HAS SHOWN THAT THE TIP OF THE INSTRUMENT IS STRONGLY BENT. ALSO WE FOUND MARKS OF HEAVY HAMMER BLOWS AT THE HOUSING OF THE TURNING KNOB AND HOLDER SHAFT. THE KIND OF THE DAMAGES LET US ASSUME THAT A MECHANICAL OVERLOAD IN COMBINATION WITH AN UNDUE HIGH CAUDAL OR CRANIAL STRESS CAUSED THIS DEFORMATION. NO PRODUCT FAULT COULD BE DETECTED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED:ALIF VISIOS PROCEDURE: DURING THE PROCEDURE THE IMPLANT HOLDER COULD NOT BE ATTACHED TO THE TRIAL IMPLANT AND IMPLANT, VISIOS. THE TIP OF THE IMPLANT HOLDER SEEMS TO BE MIS ALIGNED. THE SURGEON MANAGED TO ATTACH THE IMPLANT EVEN THOUGH THE FIXATION WAS NOT COMPLETE. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAL SPACER HANDLE TRIAL SPACER HANDLE NKB SYNTHES GMBH 1078231

    Patients

    Seq Age Sex Outcome Treatment
    1