BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYSTON STRAIGHT INLINE INSERTER

    MDR report key: 22328378 · Received June 25, 2025

    Report

    Report Number
    3012447612-2025-00248
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 26, 2025
    Report Date
    September 30, 2025
    Manufacturer
    ZIMMER BIOMET SPINE, INC.
    Product Code
    MAX
    UDI-DI
    00888480472100
    PMA / PMN Number
    K112014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: THE REMAINDER OF THE UDI NUMBER IS UNKNOWN BECAUSE THE LOT NUMBER IS NOT AVAILABLE. D10: 14-534187 LOT 0100371 (ZYSTON STRAIGHT 7H X 20LX10W LORDOTIC SPACER). 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN H6: INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AND NO PHOTOS WERE PROVIDED, SO AN EVALUATION IS UNABLE TO BE PERFORMED. ROOT CAUSE: THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO OFF-AXIS OR EXCESSIVE FORCES APPLIED DURING USE. DHR REVIEW: THE LOT NUMBER WAS NOT REPORTED AND THE DEVICE WAS NOT RETURNED, THEREFORE A DHR REVIEW IS UNABLE TO BE PERFORMED. DEVICE USAGE: THIS DEVICE IS USED FOR TREATMENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BOTH PRONGS ON THE TIP OF A ZYSTON INSERTER BROKE OFF WHILE INSERTING THE CAGE INTO THE DISC SPACE INTRA-OPERATIVELY; THE CONNECTION BETWEEN THE INSERTER AND CAGE LOOSENED. THE THREADS OF THE CAGE WERE DAMAGED WHILE THE SURGEON WAS BACKING IT OUT TO EXCHANGE INSERTERS; THE CAGE WAS ALSO REPLACED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BOTH PRONGS ON THE TIP OF A ZYSTON INSERTER BROKE OFF WHILE INSERTING THE CAGE INTO THE DISC SPACE INTRA-OPERATIVELY; THE CONNECTION BETWEEN THE INSERTER AND CAGE LOOSENED. THE THREADS OF THE CAGE WERE DAMAGED WHILE THE SURGEON WAS BACKING IT OUT TO EXCHANGE INSERTERS; THE CAGE WAS ALSO REPLACED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2399241 ZYSTON STRAIGHT INLINE INSERTER INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX ZIMMER BIOMET SPINE, INC. NA NI 00888480472100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H10.