BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, UNKNOWN SIZE

    MDR report key: 8609683 · Received May 14, 2019

    Report

    Report Number
    3012447612-2019-00228
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    December 24, 2018
    Report Date
    October 31, 2019
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    MNH
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 510(K) NUMBER: K061441, K090523, K091067, K123451, K123549, OR K140123. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: (RESULTS, CONCLUSIONS) - THE PRODUCT WAS NOT RETURNED AND NO PHOTOS WERE PROVIDED, SO AN EVALUATION COULD NOT BE PERFORMED. AS SUCH, NO EVALUATION RESULTS ARE AVAILABLE AND NO CONCLUSIONS REGARDING THE CAUSE CAN BE DRAWN. THE LOT NUMBER WAS NOT PROVIDED, SO THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS A ROD THAT BROKE POST-OPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS A ROD THAT BROKE POST-OPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403844 ROD, UNKNOWN SIZE UNKNOWN MNH ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R