BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSORB BTM

    MDR report key: 25326500 · Received May 29, 2026

    Report

    Report Number
    3007886187-2025-00037
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 28, 2026
    Manufacturer
    POLYNOVO BIOMATERIALS PTY LTD
    Product Code
    QSZ
    PMA / PMN Number
    K172140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT AVAILABLE AND THEREFORE A DEVICE EVALUATION COULD NOT BE PERFORMED. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE COMPLETED AS A LOT NUMBER WAS NOT PROVIDED. A HIGH-LEVEL ANALYSIS WAS PERFORMED AND THERE WERE NO NON-CONFORMITIES FOUND TO BE RELATED TO THE REPORTED EVENT. A REVIEW OF THE DEVICE¿S RISK PROFILE SUGGESTS THE REPORTED EVENT DOES NOT CONSTITUTE A NEW HARM OR HAZARD. AN ADVERSE EVENT APPEARS TO HAVE OCCURRED BUT DOES NOT APPEAR TO HAVE BEEN A PROBLEM WITH THE DEVICE OR THE WAY IT WAS USED. THE REPORTED ISSUE IS A KNOWN RISK ASSOCIATED WITH THE USE OF THE DEVICE. BASED ON THE INFORMATION RECEIVED, OF INITIAL BTM APPLICATION FAILURE WAS A COMBINATION OF AN ONGOING LOCAL INFECTION AND MECHANICAL MOVEMENT OVER A HIGH-MOTION JOINT. THESE EXTERNAL, CLINICAL CIRCUMSTANCES PREVENTED THE MATRIX FROM SUCCESSFULLY ADHERING AND INTEGRATING INTO THE WOUND BED, WHICH CULMINATED IN FULL-THICKNESS FLAP NECROSIS AND NECESSITATED MULTIPLE SUBSEQUENT SURGICAL INTERVENTIONS. THIS CAUSE IS CONFIRMED BY THE SUBSEQUENT SUCCESSFUL INTEGRATION OF THE DEVICE ONCE THE INFECTION WAS CLEARED AND STRICT IMMOBILIZATION WAS IMPLEMENTED. THE IFU ADEQUATELY PROVIDES INSTRUCTIONS FOR IMPLANTATION, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. POLYNOVO COULD NOT CONFIRM A DETERIORATION OR CHANGE IN THE CHARACTERISTICS OR PERFORMANCE, OR INACCURACIES IN THE LABELLING OR INSTRUCTION FOR THE REPORTED CASE. THE RATE OF THE REPORTED ISSUE TO POLYNOVO IS CONSIDERED LOW AND ACCEPTABLE. THE CLINICAL BENEFITS CONTINUE TO OUTWEIGH THE POTENTIAL RISKS ASSOCIATED WITH THIS HAZARD/USE OF THE DEVICE. NO TREND OR DEFICIENCY HAS BEEN IDENTIFIED. POLYNOVO DOES NOT BELIEVE THAT A CORRECTIVE ACTION IS WARRANTED. POLYNOVO WILL CONTINUE TO INVESTIGATE AND MONITOR COMPLAINTS OF THIS NATURE. MFR REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    A 60-YEAR-OLD FEMALE WITH SIGNIFICANT COMORBIDITIES INCLUDING END-STAGE RENAL DISEASE, FAILED RENAL TRANSPLANT, PANCREAS TRANSPLANT, AND PREDNISONE USE WAS TREATED FOR A COMPLEX ANTERIOR KNEE WOUND WITH EXPOSED PATELLA. DURING THE POSTOPERATIVE COURSE FOLLOWING VASCULAR BYPASS, THE PATIENT DEVELOPED EXTENSIVE INCISIONAL NECROSIS AND SEPTIC ARTHRITIS OF THE LEFT KNEE. MULTIPLE SOFT TISSUE COVERAGE METHODS WERE ATTEMPTED, INCLUDING BTM. THE INITIAL BTM APPLICATION WAS UNSUCCESSFUL, AND THE COMPLAINT INFORMATION SUGGESTS THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, WHICH INCLUDED FLAP/TISSUE NECROSIS AND NEED FOR ADDITIONAL INTERVENTION. FOLLOWING INFECTION CLEARANCE AND IMMOBILIZATION, BTM WAS LATER REAPPLIED WITH ADJUNCTIVE NEGATIVE PRESSURE WOUND THERAPY, THEN DELAMINATED AND COVERED WITH SPLIT-THICKNESS SKIN GRAFTS. AT FOLLOW-UP, THE GRAFTS DEMONSTRATED EXCELLENT TAKE WITH FULL WOUND COVERAGE, AND THE DEVICE REMAINED IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620780 NOVOSORB BTM Absorbable synthetic wound dressing QSZ POLYNOVO BIOMATERIALS PTY LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention