BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORSAL HEIGHT ADJUSTER

    MDR report key: 6978561 · Received October 25, 2017

    Report

    Report Number
    3012447612-2017-00575
    Event Type
    Malfunction
    Date Received
    October 25, 2017
    Date of Event
    September 29, 2017
    Report Date
    March 28, 2018
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. 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 3012447612-2017-00572 - 3012447612-2017-00576.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE RETURNED HEIGHT ADJUSTER WAS EVALUATED. THERE WAS SLIGHT MATERIAL DEFORMATION FOUND AT THE TIP WHICH IS LIKELY THE RESULT OF REPETITIVE USES. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIPS OF THREE SCREWDRIVERS AND ONE PLUG DRIVER BROKE OFF, AND THE TIP OF ONE ADJUSTER BECAME TWISTED WHILE TRYING TO REMOVE PREVIOUSLY-IMPLANTED SCREWS DURING SURGERY. THE TIPS OF TWO OF THE SCREWDRIVERS REMAIN WITHIN THE PATIENT. THE SURGEON CHOSE TO LEAVE FIVE OF THE PREVIOUSLY-IMPLANTED SCREWS WITHIN THE PATIENT. THERE WERE NO REPORTS OF PATIENT INJURIES OR FURTHER PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THIS IS REPORT FOUR OF FIVE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757173 DORSAL HEIGHT ADJUSTER SCREWDRIVER HXX ZIMMER BIOMET SPINE INC. NA 570827

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR