BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRIMPER F/TRANSV-ONNECTORS

    MDR report key: 2705816 · Received August 15, 2012

    Report

    Report Number
    8030965-2012-00642
    Event Type
    Injury
    Date Received
    August 15, 2012
    Date of Event
    June 27, 2012
    Report Date
    July 18, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSP IN (B)(6) REPORTED: PT WHO HAD A CERVICAL DISLOCATION BONE FRACTURE WAS BEING TREATED WITH POSTERIOR CERVICAL SPINAL FUSION USING THE SYNAPSE AND INSERTED PS TO C5-TH2. DURING THE ADDITION OF A TRANSCONNECTOR AT FINAL FIXATION THE EDGE OF THE CRIMPER BROKE AND WENT INTO THE PT. SURGEON WAS UNAWARE OF THE CRIMPER BREAKING DURING THE PROCEDURE AND IT WAS FOUND AFTER THE PROCEDURE ON POST OP X-RAYS. SURGEON RETURNED THE PT TO THE OPERATING ROOM AND REMOVED THE BROKEN PIECE OF THE CRIMPER. SURGEON NOTED HE DID NOT FEEL THE CRIMPER BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRIMPER F/TRANSV-ONNECTORS CRIMPER HXS SYNTHES GMBH T941969

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention