BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, UNKNOWN TYPE

    MDR report key: 8703329 · Received June 17, 2019

    Report

    Report Number
    3012447612-2019-00262
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Report Date
    November 22, 2019
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: NEXTGEN ALTIUS OCT SYSTEM OR NEXTGEN ALTIUS OCT SYSTEM. UDI NUMBER: NA. 510(K) NUMBER: K113593 OR K122378. 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED AND NO PHOTOS WERE PROVIDED, SO AN EVALUATION COULD NOT BE PERFORMED. AS SUCH, NO EVALUATION RESULTS ARE AVAILABLE AND NO CONCLUSIONS REGARDING THE CAUSE CAN BE DRAWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LINEUM SCREW HEAD BROKE APPROXIMATELY 6-7 YEARS AGO. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LINEUM SCREW HEAD BROKE APPROXIMATELY 6-7 YEARS AGO. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496723 SCREW, UNKNOWN TYPE SEE H10 KWP ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1