BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACER LAT PEEK 8DEG 55L X 26W X 10H

    MDR report key: 6188634 · Received December 20, 2016

    Report

    Report Number
    3004485144-2016-00386
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    November 15, 2016
    Report Date
    January 23, 2018
    Manufacturer
    ZIMMER BIOMET SPINE
    Product Code
    MAX
    PMA / PMN Number
    PK103666
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 3004485144-2016-00387.

    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 SPACER WAS EVALUATED. A PORTION OF THE DISTAL END WAS FRACTURED AROUND THE THREADED AREA WHICH ATTACHES TO THE INSERTER. IT IS LIKELY THAT THE INSERTER WAS HELD SOMEWHAT OUT OF ALIGNMENT OR HIT AT A SLIGHT ANGLE WHILE TAMPING WHICH WOULD HAVE OVERCOME THE MECHANICAL CAPABILITIES OF THE IMPLANT IN THIS DIRECTION CAUSING IT TO FAIL. IT IS ALSO POSSIBLE THAT THE IMPLANT WAS TOO LARGE FOR THE INTENDED SPACE AND REQUIRED HIGHER THAN TYPICAL FORCE TO MOVE IT INTO PLACE. 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 TWO SPACERS BROKE DURING INSTALLATION. ONE OF THE PIECES ENDED UP MIGRATING TO THE CONTRALATERAL SIDE, CAUSING THE PATIENT TO BE FLIPPED OVER SO THAT THE PIECE COULD BE REMOVED. IT WAS REPORTED THAT ALL PIECES WERE SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED USING ALTERNATIVE IMPLANTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841745 SPACER LAT PEEK 8DEG 55L X 26W X 10H LANX LATERAL MAX ZIMMER BIOMET SPINE NA L555153

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention