BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM X 16MM VARIABLE SCREW

    MDR report key: 15605785 · Received October 14, 2022

    Report

    Report Number
    3012447612-2022-00228
    Event Type
    Malfunction
    Date Received
    October 14, 2022
    Report Date
    March 30, 2023
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    KWQ
    PMA / PMN Number
    K080646
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER: J17108, J33766, OR J44339. 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. REFERENCE REPORT 3012447612-2022-00229.

    Additional Manufacturer Narrative · 0

    D4 EXPIRATION DATE: OCT 24, 2029 OR OCT 9, 2029 OR SEP 30, 2030. D4 UDI NUMBER: (B)(4). H4: (B)(6), 2019 OR (B)(6), 2019 OR (B)(6), 2020. CORRECTIONS IN D4: UDI NUMBER. ADDITIONAL INFORMATION IN D4: EXPIRATION DATE, H4, AND H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION -THE PRODUCT WAS NOT RETURNED HOWEVER, THE COMPLAINT WAS CONFIRMED BY THE PROVIDED X-RAYS. POTENTIAL ROOT CAUSE -A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO EXCESSIVE FORCES EXPERIENCED POST-OPERATIVELY OR OTHER PATIENT OR SURGERY SPECIFIC FACTORS. DHR REVIEW -THE DHRS WERE REVIEWED. THERE ARE NO INDICATIONS OF MANUFACTURING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT AND THE DEVICE WAS LIKELY CONFORMING WHEN IT LEFT ZIMVIE¿S CONTROL. 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 THE TWO MAXAN SCREWS PLACED AT C4 IN A C4/5 SINGLE LEVEL CONSTRUCT WERE BOTH FOUND BROKEN SIX MONTHS POSTOPERATIVELY. NO PLANS FOR PATIENT CARE HAVE BEEN PROVIDED TO THE MANUFACTURER. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TWO MAXAN SCREWS PLACED AT C4 IN A C4/5 SINGLE LEVEL CONSTRUCT WERE BOTH FOUND BROKEN SIX MONTHS POSTOPERATIVELY. NO PLANS FOR PATIENT CARE HAVE BEEN PROVIDED TO THE MANUFACTURER. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2446270 4.0MM X 16MM VARIABLE SCREW C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM KWQ ZIMMER BIOMET SPINE INC. NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown