BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYSTON STRAIGHT INLINE INSERTER

    MDR report key: 5786167 · Received July 12, 2016

    Report

    Report Number
    3004485144-2016-00144
    Event Type
    Injury
    Date Received
    July 12, 2016
    Report Date
    March 16, 2017
    Manufacturer
    BIOMET SPINE - BROOMFIELD
    Product Code
    MAX
    PMA / PMN Number
    PK112014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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. REPORT TWO OF THREE FOR THE SAME EVENT; SEE ALSO 3004485144-2016-00143 AND 00145.

    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. REPORT TWO OF THREE FOR THE SAME EVENT; SEE ALSO 3004485144-2016-00143-1 AND 00145-1.

    Additional Manufacturer Narrative · 1

    THE RETURNED INSERTER WAS EXAMINED. THERE WERE NO SIGNS OF COSMETIC DAMAGE OR DEFORMITIES. THERE IS NO EVIDENCE THAT THE METAL FRAGMENTS WERE PRODUCED FROM THIS INSERTER. 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 WHILE THE SURGEON WAS IMPACTING A CAGE WITH ZYSTON STRAIGHT INSERTER STRAIGHT HANDLE AT MIS-TLIF OPERATION; SOMETHING LIKE SMALL METAL PARTICLES/POWDER WERE SEEN FROM THE INSERTER HANDLE OR SHAFT. METAL PARTICLES FROM THE BLACK 1/4 SQUARE T-HANDLE UPON IMPACTION, WAS ALSO OBSERVED. IT IS UNKNOWN IF THE SMALL PARTICLES/POWDER FELL INTO THE PATIENT. THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441205 ZYSTON STRAIGHT INLINE INSERTER INSERTER MAX BIOMET SPINE - BROOMFIELD N/A 038281

    Patients

    Seq Age Sex Outcome Treatment
    1 Other