BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM IMF SCREW SELF-DRILLING 8MM

    MDR report key: 4094038 · Received September 16, 2014

    Report

    Report Number
    1000562954-2014-10174
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 1, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    DZL
    PMA / PMN Number
    PK010527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE MANUFACTURING INVESTIGATION REPORTED ONLY THE HEAD WITH PARTIAL THREAD WAS RETURNED. THE COMPLETE DISTAL PART IS MISSING. WITHOUT FURTHER DETAILS THE INVESTIGATION WAS NOT ABLE TO DETERMINE WHAT CAUSED THE CRACK OF THE SCREW. THE COMPLAINT CONDITION IS LIKELY THE RESULT OF A HIGH MECHANICAL FORCE CAUSED A MATERIAL OVERLOADING WHICH FINALIZED INTO THE CRACK. INVESTIGATION OF DOCUMENTATION FOR PRODUCTION AND MATERIAL PROVIDES EVIDENCE THAT THE SCREW WAS PRODUCED UNDER SPECIFICATIONS IN 2014. FAILURE IN MATERIAL OR PRODUCTION COULD NOT BE DETECTED. 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: IT WAS REPORTED DURING THE IMPLANTATION 5 SCREW THREADS WERE CRACKED. ONE OF THE 5 DAMAGED SCREWS WILL BE RETURNED THE OTHER 4 WILL NOT BE RETURNED. IT WAS REPORTED THERE WAS NO PATIENT HARM. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573696 2.0MM IMF SCREW SELF-DRILLING 8MM SCREW, FIXATION, INTRAOSSEOUS DZL SYNTHES MEZZOVICO 8934941

    Patients

    Seq Age Sex Outcome Treatment
    1