BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOFLEX BONE CEMENT KIT

    MDR report key: 23201006 · Received October 2, 2025

    Report

    Report Number
    3008583793-2025-00005
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    August 25, 2025
    Report Date
    October 2, 2025
    Manufacturer
    TEKNIMED
    Product Code
    LOD
    PMA / PMN Number
    K162206
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IFU STATES THAT "THE SURGEON I S RESPONSIBLE FOR ANY COMPLICATIONS OR HARMFUL CONSEQUENCES WHICH MIGHT RESULT FROM AN ERRONEOUS INDICATION OR OPERATIVE TECHNIQUE, IMPROPER USE OF THE EQUIPMENT AND FAILURE TO COMPLY WITH THE SAFETY INSTRUCTIONS GIVEN IN THE DIRECTIONS FOR USE. NEITHER THE ZAVATION MANUFACTURER NOR THE AUTHORIZED ZAVATION REPRESENTATIVE CAN BE HELD RESPONSIBLE FOR THESE COMPLICATIONS." UNDER THE ADVERSE EVENTS PORTION OF THE IFU IT STATES" - LEAK OF CEMENT WITH COMPRESSION OF THE SPINAL CORD POSSIBLY RESULTING IN PARALYSIS OR LOSS OF SENSITIVITY;" UNDER "IMPORTANT INFORMATION TO PHYSICIANS- PERCUTANEOUS VERTEBROPLASTY OR KYPHOPLASTY PROCEDURES SHOULD ONLY BE PERFORMED IN MEDICAL SETTINGS IN WHICH EMERGENCY DECOMPRESSIVE SURGERY IS AVAILABLE. - ADVERSE REACTIONS AFFECTING THE CARDIOVASCULAR SYSTEM HAVE BEEN ATTRIBUTED TO ACRYLIC CEMENT. RECENT DATA INDICATE THAT THE MONOMER UNDERGOES RAPID HYDROLYSIS INTO METHACRYLIC ACID, AND THAT A SIGNIFICANT FRACTION OF THE CIRCULATING METHACRYLATE IS PRESENT IN THE FORM OF FREE ACID RATHER THAN METHYL ESTER. CORRELATION BETWEEN CHANGES IN CIRCULATING CONCENTRATIONS OF METHYL METHACRYLATE/METHACRYLIC ACID AND CHANGES IN BLOOD PRESSURE HAS NOT BEEN ESTABLISHED. - CHECK FOR ANY CHANGE IN BLOOD PRESSURE DURING AND IMMEDIATELY AFTER APPLICATION OF THE OSSEOUS CEMENT. - THE DOCTOR IS RESPONSIBLE FOR ANY COMPLICATION OR HARMFUL CONSEQUENCES, WHICH MAY RESULT FROM AN ERRONEOUS INDICATION OR OPERATING TECHNIQUE, FROM INAPPROPRIATE USE OF THE MATERIAL, OR NON-OBSERVATION OF THE SAFETY INSTRUCTIONS THAT FIGURE IN THE DIRECTIONS FOR USE. - ADDITIVES (SUCH AS ANTIBIOTICS) ARE NOT TO BE MIXED WITH THE BONE CEMENT, AS THIS WILL ALTER CEMENT PROPERTIES.

    Description of Event or Problem · 0

    PATIENT HAD A L4 AND L5 KYPHOPLASTY PERFORMED ON (B)(6) 2025 WHICH WENT AS PLANNED WITH NO OBVIOUS LEAKAGE OF CEMENT INTO THE SPINAL CANAL AND A GOOD SPREAD OF BONE CEMENT. SHE CALLED LATER THAT AFTERNOON COMPLAINING OF BILATERAL LEG PAIN AND WEAKNESS AND WAS TOLD TO GO TO THE ER. SHE HAD A CT SCAN WHICH SHOWED LEAKAGE OF CEMENT INTO THE SPINAL CANAL AT L5 CAUSING SEVERE STENOSIS AND WAS EVALUATED BY NEUROSURGERY WHO PERFORMED A LAMINECTOMY AND NEUROFORATOMY AT L5 AND DECIDED TO PERFORM THE SAME AT L4 DUE TO STENOSIS HOWEVER NOT FROM CEMENT AT L4. THE PATIENT IS DOING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2623487 OSTEOFLEX BONE CEMENT KIT CEMENT MIXER & BONE CEMENT LOD TEKNIMED VCF-OSFL

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention