BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12MM OPTIO-C VARIABLE SELF-DRILLING SCREW

    MDR report key: 16833901 · Received April 28, 2023

    Report

    Report Number
    3012447612-2023-00123
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Report Date
    June 26, 2024
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    KWQ
    UDI-DI
    00889024329713
    PMA / PMN Number
    K141500
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.REFERENCE REPORTS 3012447612-2023-00120.

    Additional Manufacturer Narrative · 0

    CORRECTIONS IN G1 AND H3. ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. INSPECTION: THE RETURNED DEVICES MATCH THE INFORMATION IN THE COMPLAINT FILE AND WERE EXAMINED. VISUAL INSPECTION REVEALED THE SCREWS ARE LASER MARKED WITH A 3 DIGIT LOT CODE "OKO". A SEARCH FOR THE DHR FOR THIS LOT NUMBER FOUND THAT THE SCREWS ARE ACTUALLY PART NUMBER 07.00812.004 TRINICA SELF DRILLING SCREWS, LOT NUMBER 63059101. DHR REVIEW: THE DHR WAS REVIEWED. THE DOCUMENTS SHOWED THERE WERE NO INDICATIONS OF MANUFACTURING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. HOWEVER IT WAS LATER FOUND THAT THE DEVICE WAS IMPROPERLY LABELED WHEN REPACKAGED. POTENTIAL ROOT CAUSE: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO IMPROPERLY REPACKAGING RETURNED PRODUCTS. DEVICE USAGE: THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISTRIBUTOR RECEIVED FOUR SCREWS LABELED AS OPTIO-C SELF-DRILLING VARIABLE SCREWS, BUT THEY ARE NOT OPTIO-C SCREWS; THEY APPEAR TO BE TRINICA STANDARD/SELECT SELF-DRILLING VARIABLE SCREWS. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISTRIBUTOR RECEIVED FOUR SCREWS LABELED AS OPTIO-C SELF-DRILLING VARIABLE SCREWS, BUT THEY ARE NOT OPTIO-C SCREWS; THEY APPEAR TO BE TRINICA STANDARD/SELECT SELF-DRILLING VARIABLE SCREWS. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806621 12MM OPTIO-C VARIABLE SELF-DRILLING SCREW OPTIO-C ANTERIOR CERVICAL SYSTEM KWQ ZIMMER BIOMET SPINE INC. NA 63059101 00889024329713

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose