BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM IMF SCREW SELF-DRILLING 8MM

    MDR report key: 5086639 · Received September 18, 2015

    Report

    Report Number
    2520274-2015-15948
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 4, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    DZL
    PMA / PMN Number
    PK010527
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE BROKE DURING INSERTION; DEVICE NOT CONSIDERED IMPLANTED/EXPLANTED. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: INTER-MEDULLARY FEMORAL (IMF) SCREW WAS BEING REMOVED AND THE HEAD OF IT BROKE OFF. THE PATIENT OUTCOME WAS REPORTED AS SUCCESSFUL. X-RAY IS AVAILABLE. NO DELAY TO SURGERY KNOWN. NO ADVERSE EVENT CAUSED TO PATIENT. THE PROCEDURE WAS AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A FRACTURED MANDIBLE. WHILST INSERTING ONE OF THE SELF-DRILLING IMF SCREWS INTO THE MANDIBLE USING A SYNTHES SELF-DRILLING IMF SCREW KIT, THE SCREW HEAD SHEARED OFF FROM THE THREAD LEAVING THE THREAD STILL IN THE MANDIBULAR BONE. ANOTHER IMF SCREW WAS PLACED JUST INFERIOR TO THE FRACTURED SCREW WITH NO ISSUES. FURTHER COMMENT RECEIVED FROM THE SURGEON: THE SURGEON BELIEVES THAT THE FRAGMENT WILL STAY IN THE BONE AND UNLIKELY TO MIGRATE THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618023 2.0MM IMF SCREW SELF-DRILLING 8MM SCREW FIXATION INTRAOSSEOUS DZL SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention