BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MMF SCREW

    MDR report key: 5000161 · Received August 13, 2015

    Report

    Report Number
    9610905-2015-00038
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    July 24, 2015
    Report Date
    August 10, 2015
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    DZL
    PMA / PMN Number
    K042573
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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, A FOLLOW-UP REPORT WILL BE SENT. DEVICE WAS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    DURING IMPLANTATION, THE SCREW BROKE OFF AT THE SHAFT. A PORTION OF THE SCREW SHAFT STILL REMAINS IN THE PATIENT'S MAXILLA. NO SECONDARY SURGERY IS SCHEDULED TO REMOVE THE SCREW SHAFT FROM THE PATIENT'S BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536565 MMF SCREW BONE FIXATION SCREW DZL KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG 25-092-12-09 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other