BEUDAMED
    FDA Adverse Event Injury Summary report: N

    34.0MM, STANDARD ACUTRAK 2® BONE SCREW

    MDR report key: 6107291 · Received November 16, 2016

    Report

    Report Number
    1017294-2016-00117
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    October 31, 2016
    Report Date
    November 1, 2016
    Manufacturer
    CONMED CORPORATION
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEGAL MANUFACTURER ACUMED, LLC HAS THE COMPLAINT INVESTIGATION RESPONSIBILITY AND NOTIFICATION HAS BEEN SENT TO THE MANUFACTURER. A FOLLOW-UP AND FINAL WILL BE FILED BY ACUMED, LLC WITH THE EVALUATION RESULTS AND/OR INVESTIGATION FINDINGS. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A 34.0MM, STANDARD ACUTRAK 2 BONE SCREW WAS USED IN A "DIP FUSION OF THE 2ND TOE" PROCEDURE ON (B)(6) 2016 AND THAT THE SURGERY WAS COMPLETED AS INTENDED WITH NO PROBLEMS OR COMPLICATIONS NOTED. HOWEVER, THE REPORT FURTHER STATED THAT DURING ONE OF THE POST-OPERATIVE FOLLOW-UP VISITS, THE SURGEON DISCOVERED THAT THE "FIXATION HAD FAILED" AND THIS WAS DUE TO "PATIENT COMPLIANCE" ISSUE. AS REPORTED, THE PATIENT STRUCK HIS OPERATIVE TOE MULTIPLE TIMES LEADING TO THE FAILURE OF FIXATION AND RESULTING IN A REVISION SURGERY ON (B)(6) 2016 TO REMOVE THE "LOOSE SCREW" BY CUTTING IT OUT OF THE BONE. USING ANOTHER LIKE-SCREW, THE REVISION SURGERY WAS COMPLETED WITH NO ISSUES OR PATIENT INJURY REPORTED. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION OR ANY INDICATION THAT A LONG TERM ADVERSE EFFECT HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756585 34.0MM, STANDARD ACUTRAK 2® BONE SCREW FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI CONMED CORPORATION 380104

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention