BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSORB BTM

    MDR report key: 12089913 · Received June 30, 2021

    Report

    Report Number
    3007886187-2021-00002
    Event Type
    Injury
    Date Received
    June 30, 2021
    Report Date
    June 30, 2021
    Manufacturer
    POLYNOVO BIOMATERIALS PTY LTD
    Product Code
    FRO
    PMA / PMN Number
    K172140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6) AND WAS STATED IN A LITERATURE ARTICLE BY LI H, ET AL "EXPERIENCE WITH NOVOSORB¿ BIODEGRADABLE TEMPORISING MATRIX IN RECONSTRUCTION OF COMPLEX WOUNDS"; ANZ JOURNAL OF SURGERY. 2021; 03 JUNE. IT WAS REPORTED BY A COMPANY STAFF MEMBER ON 07-JUN-2021. THE CASE DESCRIBES A (B)(6)-YEAR-OLD MALE PATIENT WHO HAD BTM IMPLANTED FOR "SCALP SCC EXCISION WITH BURRING OF THE OUTER TABLE" ON WOUND BASE "BONE". THE ARTICLE STATED THAT, % BTM INTEGRATION AT THE TIME OF SSG WAS "0%" AND THE "BTM FAILED TO INTEGRATE OVER EXPOSED CALVARIUM DESPITE AN ABSENCE OF HAEMATOMA OR INFECTION". IT WAS STATED THAT INSTEAD OF % SSG TAKE AT 1 MONTH, "TRANS-POSITION FLAP USED". THE TIME FROM BTM INSET TO SSG, POSAS AND SENSATION SCORES WERE STATED AS "N/A". THE SIZE, LOT NUMBER AND NUMBER OF THE NOVOSORB BTM DEVICES APPLIED IS NOT SPECIFIED. THE DATE DEVICE WAS IMPLANTED TO THE SCALP IS UNSPECIFIED. DEVICE CAUSALITY WAS NOT PROVIDED. UPON MULTIPLE FOLLOW-UPS, THE INFORMATION BELOW WAS RECEIVED ON 18 JUNE 2021 FROM HCP, DR (B)(6): THE DOCTOR COMMENTED THAT PLACING BTM ON BONE IS DIFFICULT AND ON THE SCALP IS MORE DIFFICULT. THE DOCTOR STATED THAT FOR THIS PATIENT THERE WAS "NO REAL REASON" FOR THE BTM FAILING TO INTEGRATE. THE PATIENT HAD A HISTORY OF PREVIOUS RADIATION TO THE SCALP. IT WAS STATED THAT DESPITE BLEEDING ON THE BONE (FROM BURRING) THERE WAS NO TAKE OF BTM. THE DOCTOR COMMENTED AS TO WHETHER THERE "MAYBE HAD BEEN SOME MINOR INFECTION". SHE SAID THERE WAS NO CLINICAL SIGN OF INFECTION HOWEVER. SHE STATED ITS DIFFICULT FOR ANYTHING TO TAKE ON BONE (GRAFT OR BTM). THE DOCTOR STATED THAT THEY WERE AWARE TO ALLOW BTM TO EPITHELIALIZE FROM THE EDGES AND COMMENTED THAT THIS PATIENT HAD A LARGE DEFECT MEASURING AROUND 5CMX5CM OR 5CMX6CM. SHE COMMENTED THAT SHE HAS HAD SOME CASES THAT HAVE WORKED AND SOME OF THE AREAS WERE QUITE LARGE OR LARGER AND FURTHER COMMENTED THAT "THERE'S ONLY SO MUCH MIGRATION FROM THE PERIPHERY THAT CAN HAPPEN WHEN THE WOUND IS SO BIG" FURTHER STATING THAT "AT SOME STAGE THE CELLS NEED TO GROW THROUGH". THE PATIENT TODAY IS "FINE AND HAS NO ISSUES". IT WAS STATED THAT A "BIG FLAP" WAS PERFORMED INITIALLY BECAUSE OF THE PATIENT'S RADIATION AND STATED THAT "FLAPS TEND TO FAIL ON IRRADIATED SCALP". THE HCP CLOSED THE DEFECT WITH A TRANSPOSITION FLAP. SHE STATED IT IS DIFFICULT OVERALL TO ASSESS BONE QUALITY FURTHER ADDING IT'S NOT LIKE ASSESSING TISSUE QUALITY. MANUFACTURER'S DEVICE ANALYSIS RESULTS: MULTIPLE FOLLOW-UPS WERE CONDUCTED ON THIS CASE TO ELICIT INFORMATION FROM THIS DOCTOR AND THE DOCTOR RESPONDED ON THE 18TH JUNE 2021 WITH FURTHER INFORMATION THAT THE PATIENT OUTCOME WAS 'FINE AND HAD NO ISSUES'. THE DOCTOR FURTHER STATED THAT THE PATIENT HAD A HISTORY OF PREVIOUS RADIATION TO THE SCALP. THE INVESTIGATION HAS CONCLUDED THAT, IN THE ABSENCE OF A LOT NUMBER, A FULL BATCH REVIEW IS NOT POSSIBLE AND, AS SUCH, NO SPECIFIC DEVICE FINDINGS ARE AVAILABLE. MANY FACTORS ARE INVOLVED IN SUCCESSFUL DEVICE INTEGRATION AND A VIABLE WOUND BED BEING A PRIMARY REQUIREMENT FOR DEVICE EFFECTIVENESS. BASED ON INFORMATION OBTAINED DURING DUE DILIGENCE, THE COMPANY HAS CONCLUDED THAT THIS CASE DOES NOT ALTER THE BENEFIT : RISK OF THE DEVICE AND THAT THE LACK OF VIABLE WOUND BED AND FAILURE TO INTEGRATE IS A KNOWN INHERENT RISK OF DEVICE USE. THIS EVENT WILL CONTINUE TO BE TRENDED AS PART OF PMS.

    Description of Event or Problem · 1

    THE ALLEGED COMPLICATION WAS "BTM FAILED TO INTEGRATE, NO INFECTION". TRANSPOSITION FLAP WAS USED VIA SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992987 NOVOSORB BTM WOUND DRESSING FRO POLYNOVO BIOMATERIALS PTY LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention