BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 8MM

    MDR report key: 3686888 · Received March 19, 2014

    Report

    Report Number
    2520274-2014-10327
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    February 14, 2014
    Report Date
    February 20, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    DZL
    PMA / PMN Number
    PK963546
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDES JEY AND MQN. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. 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

    IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A BRAIN BIOPSY WHEN TWO OF THE SCREW HEADS TWISTED OFF. THE SURGEON WAS ABLE TO RETRIEVE THE FRAGMENTS AND COMPLETE THE PROCEDURE SUCCESSFULLY; A 14 MINUTE DELAY WAS REPORTED. THERE WAS NO REPORTED PATIENT HARM AND NO FURTHER DELAY WAS REPORTED. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162989 2.0MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 8MM SCREW, FIXATION, INTRAOSSEOUS DZL SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1