BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD 4TH BLADE 3MM OFFSET

    MDR report key: 7530853 · Received May 21, 2018

    Report

    Report Number
    3012447612-2018-00426
    Event Type
    Malfunction
    Date Received
    May 21, 2018
    Date of Event
    April 24, 2018
    Report Date
    October 24, 2018
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    GAD
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. THE ROD HOLDER WAS BENT. THERE WERE NO OTHER SIGNS OF DAMAGE ON THE DEVICE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. THE LABELING WAS REVIEWED AND FOUND TO CONTAIN INSTRUCTIONS REGARDING PROPER DEVICE USAGE. THE PATIENT WAS OF LARGE BUILD CAUSING EXCESSIVE FORCE TO BE PLACED ON THE DEVICE DURING USE RESULTING IN THE DEVICE BENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OFFSET BLADE BENT DURING SURGERY WHILE TRYING TO RETRACT AN EXTREMELY TIGHT ILIAC MUSCLE. THE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE WITHOUT REPORTED PATIENT IMPACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OFFSET BLADE BENT DURING SURGERY WHILE TRYING TO RETRACT AN EXTREMELY TIGHT ILIAC MUSCLE. THE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE WITHOUT REPORTED PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371984 ROD 4TH BLADE 3MM OFFSET RETRACTOR GAD ZIMMER BIOMET SPINE INC. NA TU01769

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR