BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    MDR report key: 3451777 · Received November 6, 2013

    Report

    Report Number
    8030965-2013-05210
    Event Type
    Injury
    Date Received
    November 6, 2013
    Report Date
    October 7, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL 510K NUMBER: K092929. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE STERILIZATION DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ACCORDING TO THE ATTACHED CERTIFICATE THE STERILIZATION WAS PERFORMED AS REQUIRED. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING THE FOLLOWING: IT WAS REPORTED THAT THE THREE MATRIX CASES DONE ON SATURDAY (B)(6) 2013, HAVE ALL BECOME INFECTED AND TWO OF THOSE CASES HAVE BEEN BROUGHT BACK FOR WASHOUTS ALREADY. IT IS BELIEVED THAT THE CAUSE OF THE INFECTIONS IS THE NEW BONE SUBSTITUTE THE SURGEON WAS TRYING, THE GENEX PUTTY. IN ALL THREE CASES HE USED 10CC ALONG WITH THE STERILE MATRIX IMPLANTS. THERE IS TRACEABILITY ON ALL THE IMPLANTS. THESE ARE THE FIRST INFECTED CASES THAT HAVE BEEN SEEN IN THE FACILITY AND THE ONLY VARIABLE THAT HAS CHANGED IS THE BONE PUTTY. THE SUPPLIER OF THE PUTTY HAS BEEN CONTACTED AND THEY SAID THAT THEY HAVE NEVER HAD A PROBLEM LIKE THIS. THESE MATRIX CASES MAY END UP NEEDED REVISIONS DOWN THE LINE IF THE INFECTIONS ARE NOT RESOLVED. THE PATIENT IS DOING WELL. NO ARTICLE WAS RECEIVED FOR INVESTIGATION AND NO FURTHER INFORMATION WAS PROVIDED. THREE COMPLAINTS HAVE BEEN OPENED FOR EACH OF THE THREE MATRIX CASES, (B)(4). THIS IS REPORT 7 OF 12 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571917 PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM NKB SYNTHES GMBH 8406177

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention