BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYAXIAL SCREW (DIA. 3.5 MM X 14 MM L)

    MDR report key: 15531387 · Received October 3, 2022

    Report

    Report Number
    3012447612-2022-00217
    Event Type
    Injury
    Date Received
    October 3, 2022
    Date of Event
    August 22, 2022
    Report Date
    March 30, 2023
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    KWP
    UDI-DI
    00889024320925
    PMA / PMN Number
    K133556
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 3012447612-2022-00219.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: DEVICE INSPECTION REVEALED THAT TWO PIECES FROM LOT ABQ HAD CRACKS IN THE WELD ON ONE SIDE. THE THIRD PIECE FROM LOT ABQ HAD BOTH WELDS BROKEN, CAUSING THE LOWER HOUSING TO BREAK INTO ITS TWO PIECES AND ALLOWING THE SCREW COMPONENTS TO DISASSEMBLE. THE WELD PENETRATION DEPTH WAS CONFIRMED TO BE GREATER THAN MINIMUM SPECIFICATION. POTENTIAL CAUSE: THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO THE PATIENT'S FALL OR OTHER UNKNOWN PATIENT AND OPERATIONAL FACTORS. DHR REVIEW: PER DHR REVIEW, THE PARTS WERE LIKELY CONFORMING WHEN THEY LEFT ZIMVIE CONTROL. DEVICE USE AND COMPATIBILITY 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 TWO VIRAGE SCREWS LOOSENED AND ONE DISASSEMBLED POST-OPERATIVELY AFTER THE PATIENT MAY HAVE FALLEN. A REVISION SURGERY WAS PERFORMED WHERE THE THREE SCREWS WERE REMOVED AND REPLACED, AND THE CONSTRUCT WAS EXTENDED FROM LEVELS C4 - T2 TO C3 - T2. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO VIRAGE SCREWS LOOSENED AND ONE DISASSEMBLED POST-OPERATIVELY AFTER THE PATIENT MAY HAVE FALLEN. A REVISION SURGERY WAS PERFORMED WHERE THE THREE SCREWS WERE REMOVED AND REPLACED, AND THE CONSTRUCT WAS EXTENDED FROM LEVELS C4 - T2 TO C3 - T2. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768346 POLYAXIAL SCREW (DIA. 3.5 MM X 14 MM L) VIRAGE OCT SPINAL FIXATION SYSTEM KWP ZIMMER BIOMET SPINE INC. NA ABQ 00889024320925

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R