BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEFT LATERAL BENDER

    MDR report key: 7148325 · Received December 27, 2017

    Report

    Report Number
    3012447612-2017-00702
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    November 27, 2017
    Report Date
    May 31, 2018
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    HXW
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE RETURNED ROD BENDER WAS EXAMINED. THE TIP OF THE ROD SLOT HAS FRACTURED OFF. THE CAUSE IS LIKELY ATTRIBUTED TO USING THE BENDER TO MAKE A SHARP OR REVERSE BEND. THE LABELING WAS REVIEWED AND FOUND TO CONTAIN INSTRUCTIONS REGARDING THE PROPER USAGE OF THE DEVICE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A CORONAL BENDER BROKE OFF DURING SURGERY. THE TIP WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE BENDER. THERE WERE NO REPORTS OF PATIENT IMPACTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928702 LEFT LATERAL BENDER BENDER HXW ZIMMER BIOMET SPINE INC. NA PP96J

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR