BEUDAMED
    FDA Adverse Event Injury Summary report: N

    90MM X 90MM RIGID OSTEOFORM MESH PLATE

    MDR report key: 18188418 · Received November 21, 2023

    Report

    Report Number
    2027754-2023-00052
    Event Type
    Injury
    Date Received
    November 21, 2023
    Report Date
    November 21, 2023
    Manufacturer
    OSTEOMED, LLC
    Product Code
    DZL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED FOR THE PART NUMBERS ASSOCIATED WITH THIS COMPLAINT, AS THE BATCH/LOT NUMBER IS UNKNOWN. A TWO-YEAR REVIEW OF THE COMPLAINT DATABASE IDENTIFIED ONE (1) COMPLAINT FOR PART-NUMBER 218-2004, WHICH IS THE COMPLAINT WITHIN THIS REPORT. FOR THE SAME TIMEFRAME, A SEARCH IDENTIFIED TWO (2) COMPLAINTS FOR THE 217-16XX PART NUMBER FAMILY, ONE OF WHICH IS RELATED TO POST-OP ALLERGIC REACTION/HYPERSENSITIVITY AND IS THE COMPLAINT WITHIN THIS REPORT. NO ADDITIONAL COMPLAINTS WERE IDENTIFIED FOR THE REPORTED ISSUE OF POST-OP ALLERGIC REACTION/HYPERSENSITIVITY. THERE WERE NO DETAILS PROVIDED ON THE REPORTED REACTION AND FOLLOW-UP ATTEMPTS DID NOT SUCCEED IN OBTAINING ANY FURTHER INFORMATION. BASED ON THE REVIEW OF RISK DOCUMENTATION, POTENTIAL CAUSES OF POST-OP ALLERGIC REACTION ARE MATERIAL NOT TO SPECIFICATION, INADEQUATE DESIGN, OR HUMAN ERROR (FAILURE TO DETERMINE PATIENT ALLERGIES). HOWEVER BASED ON THE LIMITED INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE COULD NOT BE DETERMINED. RELATED REPORT: 2027754-2023-00053.

    Description of Event or Problem · 0

    THE PATIENT CALLED INTO THE OSTEOMED CUSTOMER SERVICE DEPARTMENT REGARDING OSTEOMED PART NUMBERS 218-2004 AND 217-1604. THE PATIENT REPORTED SHE IS HAVING A REACTION TO THE METAL(S) IN THESE PRODUCTS AND REQUESTED THE METAL COMPOSITION IN THESE PRODUCTS. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE MULTIPLE FOLLOW UP ATTEMPTS. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925865 90MM X 90MM RIGID OSTEOFORM MESH PLATE SCREW, FIXATION, INTRAOSSEOUS DZL OSTEOMED, LLC 218-2004

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other