BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM DRILL BIT WITH 12MM STOPQC

    MDR report key: 3081952 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11147
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 28, 2012
    Report Date
    March 28, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. (S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    CONSULTANT REPORTED: DURING AN ACDF AT LEVELS C5-C6, C6-C7 USING ZERO-P SYSTEM, THE SURGEON WAS TRYING TO FIND THE PROPER TRAJECTORY THROUGH THE INSERTER WITH THE DRILL. HE DID NOT GET THE CORRECT ANGLE, SO EXERTED PRESSURE ON DRILL AND TIP OF BIT BROKE OFF IN SCREW PATH. TIP WAS RETRIEVED, ANOTHER DRILL BIT WAS USED AND SURGEON COMPLETED PROCEDURE. THIS IS 1 OF 1 REPORTS FOR THIS EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183265 2.0MM DRILL BIT WITH 12MM STOPQC OVE SYNTHES GMBH 2638904

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR