BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BC DISTRACT-BODY END ACTIV DISTRACTION-L

    MDR report key: 3120047 · Received May 20, 2013

    Report

    Report Number
    8030965-2013-02271
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 22, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MQN
    PMA / PMN Number
    K060138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REQUEST FOR THE DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN MADE. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    DEVICE WAS MANUFACTURED IN MAY 2008. INVESTIGATION COORDINATED BY (B)(4). REPORT RECEIVED INDICATES THE INVESTIGATION FOUND THAT THE SLOTTED SHAFT END OF THE BC DISTRACTOR BODY WAS WIDENED UP. THE SETTING SCREW THEREFORE CANNOT BE FIXED ANYMORE TO THE INSTRUMENT. THE LOT IN QUESTION WAS MANUFACTURED IN MAY 2008 AND DISTRIBUTED IN NOVEMBER 2008 TO (B)(6). WE ARE NOT AWARE OF ANY OTHER SIMILAR COMPLAINTS REGARDING THIS ARTICLE/ LOT NUMBER AND ASSOCIATED WITH THE REPORTED PROBLEM. NO PRODUCT RELATED FAULT WAS FOUND. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER IS AN UNKNOWN LOT NUMBER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A SURGERY ON AN UNKNOWN DATE, THE DOCTOR TRIED TO ASSEMBLE THE FOOTPLATE ON THE DISTRACTOR BODY. HE FOUND THAT THE FOOTPLATE WAS STILL LOOSEN EVEN WHEN TIGHTEN THE END MACHINE SCREWS. IT WAS SWAPPED OUT FOR ANOTHER FOOTPLATE BUT THE PROBLEM WAS THE SAME. THE DISTRACTOR BODY WAS SWAPPED OUT, WHICH FIXED THE PROBLEM. HE CONCLUDED THE DISTRACTOR BODY WAS FAULTY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221448 BC DISTRACT-BODY END ACTIV DISTRACTION-L MQN SYNTHES GMBH 080117

    Patients

    Seq Age Sex Outcome Treatment
    1