BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    MDR report key: 10440489 · Received August 22, 2020

    Report

    Report Number
    3012447612-2020-00495
    Event Type
    Injury
    Date Received
    August 22, 2020
    Date of Event
    July 29, 2020
    Report Date
    February 15, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS CONFIRMED. MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. DEVICE EVALUATION: THE TWO VITALITY SCREW 6.5 X 40 ITEM: 07.02000.074 ARE FRACTURED AS REPORTED THE COMPLAINT. THE REMAINING RETURNED ITEMS WERE TESTED BUT DID NOT SHOW SIGNS OF DEFORMATION AND PASSED ALL FUNCTIONAL TESTS. POTENTIAL CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO A TRAUMATIC EVENT POST-OP, FAILURE TO FOLLOW POST-OP CARE INSTRUCTIONS, PATIENT FACTORS OR OTHER OPERATING CONDITIONS THAT ARE NOT KNOWN. DHR REVIEW AND RELATED ACTIONS: PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. NO ACTIONS REQUIRED. THIS EVENT IS NOT RELATED TO ANY CURRENT ACTIONS OR RECALLS OR PRODUCT HOLDS. DEVICE USE: THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED THAT CHANGES THE INFORMATION PROVIDED IN THIS REPORT. REFERENCE REPORTS 3012447612-2020-00461 TO 3012447612-2020-00474, 3012447612-2020-00495, AND 3012447612-2020-00496.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS PSUEDOARTHROSIS AND BACK PAIN. DURING THE PROCEDURE IT WAS DISCOVERED THAT THE RIGHT AND LEFT S1 VITALITY PEDICLE SCREWS WERE BROKEN. THE SCREWS WERE REMOVED AND REPLACED WITH ALTERNATE LARGER SCREWS TO COMPLETE THE CASE. THERE WERE NO ADDITIONAL PATIENT IMPACTS REPORTED. THIS IS REPORT FIFTEEN OF SIXTEEN FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION IS EXTREMELY LIMITED, IT IS NOT KNOWN WHICH ZYSTON DEVICE WAS IMPLANTED. TYPE OF THE DEVICE: COMMON DEVICE NAME: ZYSTON ARC INTERBODY SPACER OR ZYSTON STRAIGHT SPACER SYSTEM OR ZYSTON STRUT OPEN TITANIUM SPACER SYSTEM. PMA/510(K): K110650 OR K112014 OR K171495. 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 REPORTS 3012447612-2020-00461 TO 3012447612-2020-00474, 3012447612-2020-00495 AND 3012447612-2020-00496.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS PSUEDOARTHROSIS AND BACK PAIN. DURING THE PROCEDURE IT WAS DISCOVERED THAT THE RIGHT AND LEFT S1 VITALITY PEDICLE SCREWS WERE BROKEN. THE SCREWS WERE REMOVED AND REPLACED WITH ALTERNATE LARGER SCREWS TO COMPLETE THE CASE. THERE WERE NO ADDITIONAL PATIENT IMPACTS REPORTED. THIS IS REPORT FIFTEEN OF SIXTEEN FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904817 ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE SEE H10 MAX ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R