BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S4 IMPLANTS

    MDR report key: 1146982 · Received August 29, 2008

    Report

    Report Number
    3005673311-2008-00027
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    May 6, 2008
    Report Date
    August 18, 2008
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    KWP
    PMA / PMN Number
    K032219
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OF EACH OF THE FOLLOWING S4 IMPLANTS DEVICES WERE INVOLVED IN THE REPORTED EVENT: MODEL NUMBER: SW777T; S4 POLYAXIAL SCREW 6.0X50MM; LOT NUMBER: 51419774. MODEL NUMBER: SW784T; BRAND NAME: S4 POLYAXIAL SCREW 7.0X40MM; LOT NUMBER: 51416725. MODEL NUMBER: SW790T; BRAND NAME: S4 SET SCREW NEW VERSION; LOT NUMBER: UNK. THE 510 (K) # K032219 APPLIES TO ALL ITEMS LISTED. THE DEVICES WERE DISCARDED; THEREFORE, COMPLETE INVESTIGATION CANNOT BE COMPLETED; HOWEVER, INFORMATION WILL BE EVALUATED.

    Description of Event or Problem · 1

    POSTERIOR LATERAL FUSION REVISION SURGERY. THE PATIENT NOTICED "SQUEAKING" WHEN THEY WOULD BEND DOWN. DR (B)(6) WENT BACK IN, TO FIND THAT ONE OF THE RODS, WAS NOT LOCKED DOWN TIGHT. HE HAD TO REPLACE TWO OF THE SCREWS; ONE OF EACH SCREW (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S4 IMPLANTS KWP AESCULAP AG & CO. KG SW777T 51419774

    Patients

    Seq Age Sex Outcome Treatment
    1 Other