BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA-GEN BIOACTIVE

    MDR report key: 16436322 · Received February 24, 2023

    Report

    Report Number
    2249852-2023-00002
    Event Type
    Injury
    Date Received
    February 24, 2023
    Date of Event
    September 23, 2022
    Report Date
    February 24, 2023
    Manufacturer
    COLLAGEN MATRIX, INC
    Product Code
    MQV
    UDI-DI
    00813954024134
    PMA / PMN Number
    K182074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    COMPLAINT WAS REPORTED FROM A CLINICAL SITE THAT COLLAGEN MATRIX, INC. IS CURRENTLY COLLECTING DATA FROM. BIA-GEN BIOACTIVE MOLDABLE (STRIP) WAS USED ON PATIENT. PATIENT HAD SURGERY FOR TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AND POSTERIOR INSTRUMENTED FUSION FOR THE TREATMENT OF HIGH-GRADE ANTEROLISTHESIS ON (B)(6) 2021. PATIENT RETURNED FOR CLINICAL FOLLOW-UP VISIT 9 MONTHS POST SURGERY ON (B)(6) 2023 AND REPORTED COMPLETE IMPROVEMENT OF SPINE SYMPTOMS THAT SHE HAD BEFORE THE SURGERY. PATIENT CONFIRMED SHE "IS HAPPY WITH THE SURGICAL OUTCOMES." HOWEVER, PATIENT COMPLAINED OF HIP PAIN (WORSENED BY AMBULATION) AND GENERALIZED MUSCLE PAIN OVER THE CERVICOTHORACIC MIDLINE REGION (WORSENED BY PALPATION AND SOMETIMES EDEMATOUS). PATIENT STATED STANDING FOR TOO LONG AND SITTING FOR TOO LONG "MAKES IT WORSE." HEAT AND IBUPROFEN "MAKE IT BETTER." THE LUMBAR SPINE X-RAYS SHOWED COMPLETE REDUCTION OF THE L4-5 HIGH-GRADE ANTEROLISTHESIS AND THE L3-L5 HARDWARE IS WELL-POSITIONED WITH NO SIGNS OF FAILUTRE. COMPLAINANT CONFIRMED NO FURTHER TREATMENT REGARDING THE SPINE SURGERY IS NEEDED. PATIENT WAS REFERRED TO PHYSIATRY TO ASSESS MUSCLE PAIN AND HIP PAIN. THERE WAS NO FURTHER INFORMATION ON PATIENT STATUS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994055 BIA-GEN BIOACTIVE MINERAL COLLAGEN COMPOSITE BIOACTIVE MOLDABLE MQV COLLAGEN MATRIX, INC CS-MCCBA-400 MCCBASAN21H1 00813954024134

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other