BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZUMA SCREWS

    MDR report key: 3117841 · Received May 13, 2013

    Report

    Report Number
    2032593-2013-00029
    Event Type
    Injury
    Date Received
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    SEASPINE, INC.
    Product Code
    MAX
    PMA / PMN Number
    K082926
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO ZUMA SCREWS PLACED INTO S1 DURING A L5-S1 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) FRACTURED IN THE SCREW SHAFTS. THE IMPLANT FAILURE WAS NOTICED BY SURGEON ON (B)(6) 2012 ABOUT TWO AND A HALF MONTHS AFTER THE INITIAL SURGERY ON (B)(6) 2012. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING INFORMATION WAS RECEIVED FROM THE SURGEON AND THE FIELD CLINICAL ENGINEER ON (B)(6) 2013. THE SURGEON DOES NOT HAVE THE IMPLANT. THE PARTIAL SCREW PART NUMBER WAS REPORTED AS 55-70XX. THE XXS DESIGNATE SCREW LENGTH WHICH WAS UNKNOWN. LOT NUMBER UNKNOWN. THE PATIENT COMPLAINED OF A SUDDEN INCREASE IN HER PAIN AND THAT WAS THE REASON THE X-RAY WAS TAKEN. THE PATIENT DENIED FALLING OR HAVING ANY OTHER TRAUMA. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211624 ZUMA SCREWS ZUMA MAX SEASPINE, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other