BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-P CONVEX H8 PEEK

    MDR report key: 3101788 · Received May 9, 2013

    Report

    Report Number
    8030965-2013-02145
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 12, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K072981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN ANTERIOR CERVICAL DECOMPRESSION FUSION (ACDF) SURGERY AT THE C5C6 ON (B)(6) 2013, A DEFECT WAS DISCOVERED IN THE SIZE 8 CONVEX ZERO P IMPLANT. THE PLATE DISLODGED FROM THE CAGE, AND THE CAGE WAS LEFT AS A STAND-ALONE SPACER AFTER MULTIPLE ATTEMPTS TO REMOVE IT FAILED. THE PLATE WAS RETRIEVED. THE SURGERY WAS DELAYED 5 TO 10 MINUTES. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204597 ZERO-P CONVEX H8 PEEK OVE SYNTHES GMBH 8250603

    Patients

    Seq Age Sex Outcome Treatment
    1