BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L SHAPE PLATE RIGHT EXTENDED

    MDR report key: 18088101 · Received November 7, 2023

    Report

    Report Number
    0001032347-2023-00416
    Event Type
    Injury
    Date Received
    November 7, 2023
    Date of Event
    September 28, 2023
    Report Date
    March 8, 2024
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K992355
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H3: DEVICE EVALUATED BY MANUFACTURER - A PRODUCT EVALUATION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED AND THE LOT NUMBER WAS NOT PROVIDED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H10 NARRRATIVE.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). D10: MEDICAL PRODUCT - ZIMMER BIOMET 2.0 X 7 MM LACTOSORB SCREW CATALOG #: 915-2301 LOT #: UNKNOWN; ZIMMER BIOMET L SHAPE PLATE RIGHT EXTENDED CATALOG #: 915-2150 LOT #: UNKNOWN; ZIMMER BIOMET L SHAPE PLATE LEFT EXTENDED CATALOG #: 915-2151 LOT #: UNKNOWN; ZIMMER BIOMET 2.0 X 7 MM LACTOSORB SCREW CATALOG #: 915-2301-EA LOT #: UNKNOWN; ZIMMER BIOMET 2.5X7MM LACTOSORB SCREW CATALOG #: 915-2308-EA LOT #: UNKNOWN. G2: FOREIGN - JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2023-00415. 0001032347-2023-00416, 0001032347-2023-00417, 0001032347-2023-00418, 0001032347-2023-00419.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND SWELLING AT THE MARGIN OF THE FORAMEN MAGNUM AFTER SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247792 L SHAPE PLATE RIGHT EXTENDED PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H10 NARRATIVE