BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XRL MEDIUM SCREW F/END-PL 2U

    MDR report key: 2903543 · Received January 9, 2013

    Report

    Report Number
    1719045-2013-00072
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQP
    PMA / PMN Number
    K103320
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MANUFACTURING RECORDS NOTED THE SCREW, EP, MEDIUM SYNEX RADIOLUCENT WAS MADE TO THE SYNTHES DRAWING. THE PRODUCT CONFORMED TO ALL REQUIREMENTS.

    Description of Event or Problem · 1

    DURING A CORPECTOMY, THE XRL CAGE WAS COMPLETELY EXPANDED THEN COLLAPSED TO REPOSITION IT. IT WAS THEN EXPANDED AGAIN AND PLACEMENT WITH A 10 TO 15 DEGREE BEND WAS VERIFIED VIA FLUOROSCOPE. EVERYTHING LOOKED OK ON THE FLUOROSCOPE SHOT. WHEN THE SURGEON LOOKED AT THE PLACEMENT IN THE PATIENT, THE CAGE LOOKED LIKE IT HAD BUCKLED WHERE THE INNER SHAFT OF THE CAGE MEETS THE OUTER SHAFT. THE SURGEON TRIED TO COLLAPSE THE CAGE TO REMOVE IT BUT COULD NOT DUE TO THE DEFORMATION. A HIGH SPEED BURR WAS USED TO CUT IT IN HALF AND THE SURGEON WAS THEN ABLE TO REMOVE THE CAGE AND IMPLANTED ANOTHER XRL CAGE WITHOUT A PROBLEM. THE SURGERY WAS PROLONGED ABOUT 15 TO 20 MINUTES. PATIENT REPORTEDLY WAS NOT COMPROMISED AND THE OUTCOME OF THE SURGERY WAS NOT ALTERED. THIS REPORT IS #1 OF 4 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11039 XRL MEDIUM SCREW F/END-PL 2U XRL MEDIUM SCREW F/END-PL 2U MQP SYNTHES MONUMENT 6941638

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention CAGE, END PLATES