BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTING TUBE HOFFMANN XPRESS 15 X 210MM

    MDR report key: 2112228 · Received April 29, 2011

    Report

    Report Number
    8031020-2011-00087
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 12, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    KTT
    PMA / PMN Number
    K073076
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. OTHER DEVICES ASSOCIATED WITH THIS EVENT ARE AS FOLLOWS: (B)(4) 5 HOLE PIN CLAMP HOFFMANN XPRESS 1 POST, (B)(4) UNIVERSAL COUPLING HOFFMAN XPRESS 15/15MM 4-5/15MM, (B)(4) UNIVERSAL COUPLING HOFFMANN XPRESS 15/15MM 4-5/15MM, (B)(4) TORQUE WRENCH HOFFMAN XPRESS 8MM 11NM.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA OUR SALES REP THAT THE FRAME DID NOT OFFER THE USUAL STABILITY USED ON A CHILD WITH NORMAL WEIGHT. SHE FURTHER STATES THAT THE FRACTURE SLUMPED DOWN IN ALL 3 TRIALS AND THE TORQUE WRENCH WAS USED AT 11 NM. THE SURGERY WAS FINISHED USING AN AO FIXATEUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONNECTING TUBE HOFFMANN XPRESS 15 X 210MM IMPLANT KTT STRYKER OSTEOSYNTHESIS SELZACH NA N30976

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other