BEUDAMED
    FDA Adverse Event Injury Summary report: N

    510MM TI ALLOY ROD W/HEX

    MDR report key: 7033688 · Received November 15, 2017

    Report

    Report Number
    3012447612-2017-00656
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    November 18, 2016
    Report Date
    February 26, 2018
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    PK061441
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REFERENCE REPORTS 3012447612-2017-00656, 3012447612-2017-00657, AND 3012447612-2018-00130.

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REFERENCE REPORT 3012447612-2017-00657.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A LEGAL CLAIM THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS PAIN AND TWO TITANIUM RODS THAT BROKE POST-OPERATIVELY DUE TO NON-FUSION. DURING THE REVISION, A PEDICLE SCREW WAS FOUND LOOSE AT LEVEL T10. THE TWO BROKEN RODS AND THE LOOSE SCREW WERE REMOVED AND REPLACED DURING THE REVISION. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A LEGAL CLAIM THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS TWO TITANIUM RODS WHICH BROKE POST-OPERATIVELY. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813933 510MM TI ALLOY ROD W/HEX EBI 5.5 HELICAL FLANGE SPINAL SYSTEM NKB ZIMMER BIOMET SPINE INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R