BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUG

    MDR report key: 7107717 · Received December 12, 2017

    Report

    Report Number
    3012447612-2017-00683
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    November 13, 2017
    Report Date
    August 3, 2018
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    MNH
    PMA / PMN Number
    PK061441
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLUG WAS NOT RETURNED; A PHOTO OF AN X-RAY WAS USED FOR EVALUATION PURPOSES. THE PLUG WAS CONFIRMED TO HAVE BACKED OUT FROM ITS ORIGINAL POSITION. THE LOT NUMBER WAS NOT PROVIDED SO THE DHR IS UNABLE TO BE REVIEWED. THE CAUSE OF FAILURE CANNOT BE DETERMINED AT THIS TIME AS THE PART WAS NOT RETURNED FOR EVALUATION.

    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 3012447612-2017-00682.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PLUGS BACKED OUT FROM THEIR MATING PEDICLE SCREWS POST-OPERATIVELY. A REVISION SURGERY HAS NOT BEEN PERFORMED TO ADDRESS THE PLUGS. NO PATIENT HARM HAS BEEN REPORTED IN ASSOCIATION WITH THIS EVENT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887406 PLUG EBI 5.5 HELICAL FLANGE SPINAL SYSTEM MNH ZIMMER BIOMET SPINE INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR