BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BC DISTRACT-BODY END ACTIV DISTRACTION-L

    MDR report key: 3225685 · Received July 14, 2013

    Report

    Report Number
    2530088-2013-01043
    Event Type
    Malfunction
    Date Received
    July 14, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 21, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORD FOR 04.315.065, BC DISTRACTOR BODY END ACT. W/U-JOINT 25MM FOR CMF DISTRACTOR, LOT NUMBER 7111868 SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DHR'S FOR COMPONENTS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DHR SHOWED NCR NUMBER WHICH WAS WRITTEN FOR THE SHIPPING ORDER FORM, F-S147, BEING INCOMPLETE. THIS NCR HAD NO EFFECT ON THE QUALITY OF THE RAW MATERIAL OR PRODUCT; IT WAS A DOCUMENTATION ERROR. THE COMPLAINT IS INVALID. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A SPLINT WAS TOO TIGHT AROUND THE DEVICE. A MANDIBULAR DISTRACTION WAS PLANNED WHICH INCLUDED MODELS, SPLINTS AND PREBENDING OF THE FOOTPLATES TO PLAN THE CORRECT FOOTPLATE/DISTRACTOR POSITIONING AND CORRECT VECTORS. THE BC FOOTPLATES AND DISTRACTOR WERE ASSEMBLED. ONCE THE OSTEOTOMY HAD BEEN PERFORMED AND THE CONSTRUCT WAS IMPLANTED, THE SURGEON USED THE ACTIVATION INSTRUMENT TO CHECK THE DISTRACTION. THERE WAS NO MOVEMENT SO THE SURGEON CONTINUED TO TURN. THE INTERNAL LEAD SCREW DISENGAGED AND THE SOFT TISSUE WAS CAUGHT IN PART OF THE DEVICE. PART OF THE PLANNING PROCEDURE INCLUDED THE DISTRACTOR CONSTRUCT TO FIT INTO A DESIGNED SPLINT. THE SURGEON COMMENTED THAT THE SPLINT WAS TOO TIGHT AROUND THE DISTRACTOR AND WAS WORRIED THAT THE JOINT BETWEEN THE ACTIVATION HEX AND THE BODY OF THE DISTRACTOR WAS DAMAGED. THE CONSTRUCT WAS REASSEMBLED AND THE SOFT TISSUE REMOVED. THE MACHINE SCREW WAS FULLY TIGHTENED. THE SURGEON DID ASK IF THERE WAS ANOTHER DISTRACTOR ON THE SET, BUT THIS WAS NOT AN OPTION. THE OTHER SIDE WAS THEN ASSEMBLED AND IMPLANTED WITH NO ISSUES. THE DISTRACTORS WERE BOTH CHECKED AND WERE DISTRACTING AND WORKING FINE. THE SURGEON DECIDED THERE SHOULD BE NO ISSUES OR PROBLEMS WITH THE IMPLANTS OR THE DISTRACTORS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO MATERIAL WAS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325233 BC DISTRACT-BODY END ACTIV DISTRACTION-L MQN SYNTHES BRANDYWINE 7111868

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Disability