BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-11062

    MDR report key: 3041893 · Received April 8, 2013

    Report

    Report Number
    2520274-2013-11062
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 19, 2012
    Report Date
    March 19, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    OVE
    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. 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. 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. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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.(B)(4)

    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. IMPLANT DATE IS (B)(6) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ZERO-P PROCEDURE THE SURGEON WAS USING THE ZERO-P VA IMPLANTS AND CONFIRMED THAT TWO OF THE ZERO-P VA IMPLANTS DID NOT HAVE THE "UP" ARROW, THAT POINTS CRANIALLY, ON THE TAB. THE SURGEON WAS ABLE TO DETERMINE THE DIRECTION OF THE IMPLANT WITH THE HELP OF THE CONSULTANT. THE SURGEON IMPLANTED THE ZERO-P VA IMPLANTS AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEMS AND NO ADVERSE EFFECT TO PATIENT. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143285 OVE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1