BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOBRACE

    MDR report key: 23189026 · Received October 1, 2025

    Report

    Report Number
    1017294-2025-00106
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    August 20, 2025
    Report Date
    October 1, 2025
    Manufacturer
    RK MANUFACTURING
    Product Code
    OWW
    PMA / PMN Number
    K203267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NEITHER THE DEVICE NOR PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF TWO REPORTS, REGARDING TWO DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: DO NOT USE THE BIOBRACE® IMPLANT IF THE TEMPERATURE SENSITIVE DOT IS RED. VISUALLY INSPECT STERILE BARRIER SYSTEM(S) FOR ANY PACKAGE INTEGRITY ISSUES THAT COULD IMPACT DEVICE STERILITY PRIOR TO ASEPTIC PRESENTATION. DO NOT USE IF ANY BREACHES IN THE STERILE BARRIER SYSTEM(S) ARE FOUND. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE BB5X250, BIOBRACE REINFORCED IMPLANT, 5 X 250 MM WAS BEING USED ON (B)(6) 2025 AND AFTER AN ¿ACL REVISION WITH BIOBRACE & BTB ALLOGRAFT FROM MTF. PATIENT PRESENTED WITH STAPHYLOCOCCUS CAPRAE INFECTION 2 WEEKS POST-OP.¿ A SECOND SURGERY WAS REQUIRED TO REMOVE THE IMPLANTS;¿ ACL FOLLOWED BY I&D WASHOUT WITH ALL IMPLANTS AND SCREWS REMOVED.¿ THE ORIGINAL PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE. PER FURTHER ASSESSMENT IT WAS REPORTED THAT "I DON¿T THINK THERE WAS ANY MALFUNCTION OF THE PRODUCT. THE PRODUCT COULD BE SEEN IN THE I&D PICTURES, INTACT. PATIENT¿S CURRENT CONDITION IS STABLE. HE HAS NOT BEEN HOSPITALIZED. HE IS ON ANTIBIOTICS. ALL IMPLANTS/HARDWARE/GRAFTS HAVE BEEN REMOVED FROM THE KNEE." THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY RELATED TO A DEVICE BEING USED DURING A PROCEDURE WITHOUT ANY REPORT OF A MALFUNCTION, WHERE THE PATIENT EXPERIENCED STAPHYLOCOCCUS CAPRAE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105619 BIOBRACE MESH, SURGICAL, ABSORBABLE, ORTHOPAEDICS, REINFORCEMENT OF TENDON OWW RK MANUFACTURING BZL30797

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other| R