BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXNEURO CONTOUR MESH 200MM X 200MM/0.6MM RIGID

    MDR report key: 3822840 · Received May 21, 2014

    Report

    Report Number
    2520274-2014-11544
    Event Type
    Injury
    Date Received
    May 21, 2014
    Report Date
    April 29, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    PK042365
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE LOT NUMBER PROVIDED COULD NOT BE VERIFIED; THEREFORE, FURTHER INVESTIGATION CANNOT BE PERFORMED. IT IS UNKNOWN IF DEVICE HAS BEEN EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    TECOMET MANUFACTURED THE TI MATRIXNEURO CONTOUR MESH, P/N 04.503.122, AND LOT 7050638. THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE (DATED (B)(6) 2012) INDICATES THAT THE PARTS WERE MADE TO REVISION ¿A¿ AND MET THE REQUIRED SPECIFICATIONS. THE PARTS WERE INSPECTED AND CONFORMED TO SYNTHES INCOMING FINAL INSPECTION SHEET. NO NONCONFORMANCE REPORTS WERE GENERATED FOR THIS LOT. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SURGEON DID CRANIOPLASTY ON (B)(6) 2013 DUE TO THE LEFT CRANIAL COLLAPSE. A PLATE WAS IMPLANTED AND NO ABNORMALITIES FOUND AT THAT TIME. IN (B)(6) 2013, THE PATIENT WENT TO HOSPITAL FOR RE-EXAMINATION AND THE COMPUTERIZED TOPOGRAPHY CHART INDICATED THE PLATE HAD MINOR CRACK, BUT NO ADDITIONAL TREATMENT WAS DONE. IN (B)(6) 2014, THE PATIENT WAS ADMITTED INTO HOSPITAL AGAIN DUE TO FACIAL PAIN. THE COMPUTERIZED TOPOGRAPHY SHOWED THE PLATED WAS BROKEN INTO SEVERAL PIECES. THE SURGEON SUGGESTED REMOVING THE PLATES; HOWEVER, IT IS UNKNOWN IF THAT HAS HAPPENED YET. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303909 TI MATRIXNEURO CONTOUR MESH 200MM X 200MM/0.6MM RIGID BONE PLATE JEY SYNTHES MONUMENT 7050638

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention