BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYSTON STR INSERTER INNER SHAFT

    MDR report key: 5786164 · Received July 12, 2016

    Report

    Report Number
    3004485144-2016-00143
    Event Type
    Injury
    Date Received
    July 12, 2016
    Report Date
    March 20, 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 ONE OF THREE FOR THE SAME EVENT; SEE ALSO 3004485144-2016-00144 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 ONE OF THREE FOR THE SAME EVENT; SEE ALSO 3004485144-2016-00144-1 AND 00145-1.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. THROUGH TESTING PERFORMED BY THE COMPLAINANT, THE MATERIAL DEBRIS WAS DETERMINED TO BE (B)(4). THERE ARE TWO SUBCOMPONENTS WITHIN THE DEVICE ASSEMBLY THAT ARE MADE FROM THAT MATERIAL. THE DEVICE WAS DISASSEMBLED AND THOSE TWO COMPONENTS WERE EXAMINED. HOWEVER, THERE WAS NO EVIDENCE OF WEAR OR DEFORMATION OF THE TWO COMPONENTS WHICH WOULD HAVE LED TO THE DEBRIS FOUND DURING THE EVENT. FURTHER EXAMINATION OF THE DEVICE DID NOT FIND ANY EVIDENCE THAT THE METAL DEBRIS ORIGINATED FROM THE DEVICE ITSELF. 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
    441714 ZYSTON STR INSERTER INNER SHAFT INSERTER MAX BIOMET SPINE - BROOMFIELD N/A 037925

    Patients

    Seq Age Sex Outcome Treatment
    1 Other