BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S4C POLYAXIAL SCREW 3.5X12MM

    MDR report key: 1436297 · Received May 1, 2009

    Report

    Report Number
    3005673311-2009-00005
    Event Type
    Malfunction
    Date Received
    May 1, 2009
    Date of Event
    January 19, 2009
    Report Date
    March 12, 2009
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    MNI
    PMA / PMN Number
    K050979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SET SCREW NUMBER MENTIONED IN THE EVENT DESCRIPTION IS AS FOLLOWS; HOWEVER, IT SHOULD BE NOTED THAT THE SET SCREW DID NOT CONTRIBUTE TO ANY POTENTIAL FAILURE: (B) (4); S4C SET SCREW NEW VERSION; LOT 51441189 (6), 51441371 (3); COMMON DEVICE NAME: KWP; 510K: K050979. DEVICES WILL BE FORWARDED TO MFR UPON RECEIPT.

    Description of Event or Problem · 1

    POSTERIOR CERVICAL FUSION 6 LEVEL C3 - T1 SCREW STRIPPED; HAD TO CHANGE SCREW THUS HAD TO CHANGE CONSTRUCT (SET SCREWS, ETC). THE THREADS ON THE LATERAL MASS SCREW ITSELF STRIPPED, NOT THE SET SCREW. THEREFORE, ALL THE SET SCREWS HAD TO BE REPLACED BECAUSE THEY HAD ALREADY BEEN TORQUED. THE SURGERY WAS DELAYED 30 TO 45 MINUTES. THE PROCEDURE WAS COMPLETED. PT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S4C POLYAXIAL SCREW 3.5X12MM MNI AESCULAP AG & CO. KG SW162T 51421256

    Patients

    Seq Age Sex Outcome Treatment
    1