BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNESYS SCREW GENERIC

    MDR report key: 3133006 · Received May 16, 2013

    Report

    Report Number
    9613350-2013-01574
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 18, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    NQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. ONCE RETURNED AND INVESTIGATED AND THE EVALUATION RESULT BECOMES AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENT RECEIVED A DYNESYS LIS SYSTEM IN L4 - S1 ON (B)(6) 2006. ON (B)(6) 2007, THE L5 SCREW WAS REPLACED BY ANOTHER DYNESYS SCREW WITH HYDROXYAPATITE COATING. THE I-SPINE SYSTEM WAS ALSO PLACED DURING THIS SURGERY FROM L1 TO L3, BILATERALLY. ON (B)(6) 2011, A FURTHER SURGERY WAS CONDUCTED DUE TO BROKEN SCREW (PLACE NOT MENTIONED) AND WAS REPLACED WITH THE I-SPINE SYSTEM. ON (B)(6) 2013, IT IS MENTIONED THAT THE DYNESYS SCREW IN L4 BROKE - ALL DYNESYS IMPLANTS WERE REMOVED. THE DISTAL TIP OF ONE L4 DYNESYS SCREW REMAINED IN THE VERTEBRAL BODY. THIS I-SPINE IMPLANTS IN L1 TO L3 REMAINED IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218785 DYNESYS SCREW GENERIC NONE NQP ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R