BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI PSPC MATRIXMANDIBLE 7X23 H ANGLE RECON PL/LEFT/2.0MM THK

    MDR report key: 3013562 · Received March 20, 2013

    Report

    Report Number
    2530088-2013-10264
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 27, 2012
    Report Date
    February 27, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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. NO SAMPLE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS COMPLAINT IS CONSIDERED INVALID FROM A MANUFACTURING PERSPECTIVE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN PLACING THE SCREWS INTO THE PLATE/MANDIBLE, THE 2.0MM MATRIX MANDIBLE SCREW PASSED THROUGH THE PLATE RATHER THAN LOCKING AS INTENDED. SURGEON USED 2.4MM MATRIX MANDIBLE SCREW AND IT WAS SUCCESSFULLY PLACED. PROCEDURE WAS COMPLETED. THE PATIENT WAS UNHARMED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115612 TI PSPC MATRIXMANDIBLE 7X23 H ANGLE RECON PL/LEFT/2.0MM THK JEY SYNTHES BRANDYWINE 6887168

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR