BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSURE TOP UNSPECIFIED

    MDR report key: 11695663 · Received April 20, 2021

    Report

    Report Number
    3012447612-2021-00126
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Report Date
    July 2, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    MNH
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELAYING ADDITIONAL INFORMATION. DEVICE EVALUATION: PRODUCT WAS NOT RETURNED AND PHOTOS WERE NOT PROVIDED, SO A DEVICE EVALUATION COULD NOT BE PERFORMED. POTENTIAL CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO TORQUE HANDLE WEAR THROUGH USE OVER TIME OR MULTIPLE STERILIZATION CYCLES, RESULTING IN THE CLOSURE TOP BEING UNDER TORQUED. DHR REVIEW AND RELATED ACTIONS: DHRS WERE UNABLE TO BE REVIEWED SINCE THE LOT NUMBERS ARE NOT KNOWN AT THIS TIME. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SET SCREWS LOOSENED POST OPERATIVELY AT THE BOTTOM OF A CONSTRUCT. NO REVISION PLANS OR FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 3 FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE CODE: SPINAL FIXATION SYSTEM OR EBI 5.5 HELICAL FLANGE SPINAL SYSTEM. DEVICE PRODUCT CODE: NKB OR MNH. PMA/510(K) NUMBER: SIMILAR TO K150896 OR K061441. 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 3012447612-2021-00127, 3012447612-2021-00128.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SET SCREWS LOOSENED POST OPERATIVELY AT THE BOTTOM OF A CONSTRUCT. NO REVISION PLANS OR FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 3 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589273 CLOSURE TOP UNSPECIFIED SEE H10 MNH ZIMMER BIOMET SPINE INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1