BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15X20MM BIOMEND

    MDR report key: 18065795 · Received November 3, 2023

    Report

    Report Number
    2648988-2023-00034
    Event Type
    Malfunction
    Date Received
    November 3, 2023
    Date of Event
    August 23, 2023
    Report Date
    December 1, 2023
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    LYC
    UDI-DI
    10381780070733
    PMA / PMN Number
    K992216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEND (0103P) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE DEVICE HISTORY RECORD (DHR) OF THE REPORTED FG LOT NUMBER 6912357 WAS REVIEWED AND NO ANOMALIES WERE FOUND DURING MANUFACTURING AND PACKAGING PROCESSES OF THE LOT WHICH COULD CONTRIBUTE AND/OR BE RELATED TO THE REPORTED CONDITION. FAILURE ANALYSIS - THE REPORTED CATALOG AND LOT NUMBER WERE CONFIRMED. THE UNIT WAS VISUALLY INSPECTED, AND A HAIR WAS OBSERVED INSIDE THE TRAY ON TOP OF THE TYVEK ENVELOPE CONTAINING THE UNIT. RETAIN SAMPLES EVALUATION: NINE (9) UNITS (1 SHIPPER BOX WITH 9 DISPENSER BOXES) WERE VISUALLY INSPECTED. DISPENSER BOXES AND PRODUCT TRAYS ARE IN GOOD CONDITION. TRAY SEALING AREA WAS COMPLETE. NO FOREIGN MATTER WAS OBSERVED ON THE INSPECTED UNIT. BASED ON THE EVALUATION OF THE RETURNED UNIT, THE COMPLAINT IS CONSIDERED CONFIRMED. ROOT CAUSE ANALYSIS - THE ROOT CAUSE FOR THE REPORTED CONDITION IS THAT MANUFACTURING PERSONNEL FAILED TO IDENTIFY THE FOREIGN MATERIAL DURING THE 100% VISUAL INSPECTION AFTER THE TRAY SEALING PROCESS. AN AWARENESS TRAINING WAS PROVIDED TO MANUFACTURING PERSONNEL TO DISCUSS THE COMPLAINT AND EMPHASIZE THE IMPORTANCE OF BEING AWARE OF THE GOWNING AND INSPECTION PRACTICES (TO OBSERVE THE SAMPLES FROM DIFFERENT ANGLES). ALSO, THE RETURNED UNIT WAS SHOWN TO THE PERSONNEL SO THEY COULD SEE WHERE THE HAIR WAS LOCATED WHICH COULD NOT BE SEEN UNLESS THE TRAY WAS TURNED SIDEWAYS. THIS IS THE FIRST COMPLAINT RELATED TO FOREIGN MATTER IN THE PERIODONTAL REGENERATION PRODUCT FAMILY FOR THE PAST 24 MONTHS.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED AN UNOPENED STERILE BIOMEND (0103P) CONTAINED A HAIR. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2207868 15X20MM BIOMEND DENTAL PRODUCTS LYC INTEGRA LIFESCIENCES CORPORATION 6912357 10381780070733

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown