BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL-FREE MAXDRIVE MICRO SCREW

    MDR report key: 4790513 · Received May 18, 2015

    Report

    Report Number
    9610905-2015-00032
    Event Type
    Injury
    Date Received
    May 18, 2015
    Report Date
    May 14, 2015
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO.
    Product Code
    HRS
    PMA / PMN Number
    K971297
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR RETURN; THEREFORE, NO PROPER EVALUATION COULD BE PERFORMED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. AS A RESULT, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.IF FURTHER INFORMATION IS ACQUIRED THAT ADDS VALUE TO THE CONTENT OF THIS REPORT AND/OR A VALID CONCLUSION CAN BE DRAWN, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SENT. DEVICE WAS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    FOLLOWING IMPLANTATION, THE SCREWS SEEMED TO HAVE BACKED OUT OR LOOSENED. A SECONDARY SURGERY WAS PERFORMED TO REMOVE THE LOOSE SCREWS AND REPLACE THE NEW ONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321468 DRILL-FREE MAXDRIVE MICRO SCREW BONE SCREW HRS KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. 25-878-05-91 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other