BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSPC MATRIXMANDIBLE DBL ANGLE RECON PLATE SMALL/2.5MM THICK

    MDR report key: 3080561 · Received April 26, 2013

    Report

    Report Number
    2530088-2013-10516
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    October 6, 2011
    Report Date
    October 24, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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. ORIGINAL AWARENESS DATE IS (B)(4) 2011. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    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 AND NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED FOR EVALUATION. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MANDIBLE RECONSTRUCTION PROCEDURE, THE HOLES IN THE SYNTHES PLATE DID NOT MATCH UP THE MATERIALISE DRILLING GUIDE. THIS MISALIGNMENT CAUSED THE SURGEON TO HAVE TO RE-DRILL THE HOLES IN THE PATIENTS FIBULA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PLATE IS CURRENTLY IN THE PATIENT. THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183357 PSPC MATRIXMANDIBLE DBL ANGLE RECON PLATE SMALL/2.5MM THICK JEY SYNTHES BRANDYWINE 6779014

    Patients

    Seq Age Sex Outcome Treatment
    1