BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPAL 10*28 H11 REVOLVABLE

    MDR report key: 3181234 · Received June 21, 2013

    Report

    Report Number
    2520274-2013-03537
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MAX
    PMA / PMN Number
    K072791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013, REPORTEDLY THE SURGEON IMPLANTED THE OPAL IMPLANT IN THE DISC SPACE BY HAMMERING THE DEVICE INTO POSITION. AFTER RELEASING THE IMPLANT FROM THE IMPLANT HOLDER, IT WAS NOTICED THAT THE IMPLANT WAS TOO FAR ANTERIORLY IN THE DISC SPACE. THE USER FACILITY TRIED TO CONNECT THE IMPLANT HOLDER AGAIN, BUT WAS UNSUCCESSFUL. THE IMPLANT SLIPPED FURTHER ANTERIORLY AND THE IMPLANT COULD NOT BE SEEN. ANOTHER 11MM IMPLANT WAS IMPLANTED. THERE WERE NO SYMPTOMS FROM THE PATIENT REPORTED. A POST-OPERATIVE CT SCAN WILL BE DONE FOR FOLLOW OP. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282254 OPAL 10*28 H11 REVOLVABLE MAX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention