BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD GRIPPER

    MDR report key: 7654871 · Received July 2, 2018

    Report

    Report Number
    3012447612-2018-00534
    Event Type
    Malfunction
    Date Received
    July 2, 2018
    Date of Event
    May 24, 2018
    Report Date
    October 17, 2018
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    GDJ
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: GDJ. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED ROD GRIPPER WAS EVALUATED. THE SCREW THAT CONNECTS THE TIPS OF THE ROD GRIPPER HAS FRACTURED DOWN THE MIDDLE, LEADING TO THE LOOSENING AND LOSS OF CONNECTIVITY. A REVIEW OF THE MANUFACTURING RECORDS DID NOT SHOW ANY ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ROD GRIPPER BROKE DURING SURGERY WHILE MANIPULATING A ROD. AN ALTERNATIVE ROD GRIPPER WAS USED TO COMPLETE THE PROCEDURE WITHOUT REPORTED PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499205 ROD GRIPPER CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY GDJ ZIMMER BIOMET SPINE INC. NA 63028625

    Patients

    Seq Age Sex Outcome Treatment
    1