BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDRT, UNKNOWN

    MDR report key: 14881188 · Received June 30, 2022

    Report

    Report Number
    1121308-2022-00047
    Event Type
    Injury
    Date Received
    June 30, 2022
    Report Date
    August 23, 2022
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    MDD
    PMA / PMN Number
    P900033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    INTEGRA DERMAL REGENERATION TEMPLATE (IDRT) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. AS A LITERATURE COMPLAINT WITH NO PRODUCT RETURNED AND AN ABSENCE OF DETAILS ON THE FAILURES, A COMPLAINT INVESTIGATION (FAILURE ANALYSIS) IS NOT POSSIBLE AS THE COMPLAINT COULD NOT BE VERIFIED. HOWEVER, THE MOST PROBABLE ROOT CAUSE IS MOST LIKELY ATTRIBUTABLE TO THE UNDERLYING HEALTH CONDITIONS OF THE PATIENTS WITHIN THE STUDY. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    4 OF 9 REPORTS. OTHER MFG REPORT NUMBERS: 1121308-2022-00045, 1121308-2022-00046, 1121308-2022-00048, 1121308-2022-00049, 1121308-2022-00050, 1121308-2022-00051, 1121308-2022-00052, 1121308-2022-00053. ACTA ORTHOPAEDICA BELGICA (2014) PUBLISHED: "OUTCOMES FOLLOWING EXTREMITY WOUND COVERAGE WITH AN ACELLULAR SKIN SUBSTITUTE (INTEGRA) : A MULTI-CENTER STUDY" THE PURPOSE OF THIS MANUSCRIPT IS TO DOCUMENT RESULTS AND COMPLICATIONS OF USE OF A REGENERATIVE DERMAL MATRIX SKIN SUBSTITUTE FOR COVERAGE OF EXTREMITY WOUNDS. A RETROSPECTIVE REVIEW AT 3 INSTITUTIONS IDENTIFIED 28 PATIENTS AND 34 WOUNDS WHO HAD UNDERGONE USE OF THIS MATERIAL (INTEGRA). COMPLICATIONS INCLUDED FAILURE IN TWO PATIENTS (4 WOUNDS). HOWEVER, OVERALL ¿TAKE¿ OF THE REGENERATIVE MATRIX WAS 86.1%. IN MOST CASES, A SPLIT THICKNESS SKIN GRAFT WAS APPLIED ON AVERAGE AT 25 DAYS FOLLOWING THE INITIAL PROCEDURE. FAILURES WERE ASSOCIATED WITH INFECTION AND IRRADIATION OF THE SURGICAL FIELD. IN THIS SERIES, USE OF THE DERMAL REGENERATIVE MATRIX WAS ASSOCIATED WITH A HIGH RATE OF SUCCESS FOR WOUND COVERAGE, OBVIATING THE NEED FOR FLAP COVERAGE OR PROLONGED DRESSING CHANGES IN MOST CASES. FURTHER SERIES ARE LIKELY TO REFINE THE KNOWN INDICATIONS AND CONTRAINDICATIONS TO USE OF THIS METHOD. TWENTY-EIGHT PATIENTS WITH 34 WOUNDS UNDERWENT APPLICATION OF THIS MATERIAL AS EITHER A BILAYER (N = 11), MONOLAYER (N = 22) OR COMBINATION (N = 1) FOR PURPOSES OF WOUND COVERAGE (TABLE I). THERE WERE 21 MALE AND 7 FEMALE PATIENTS ; AVERAGE AGE WAS 49.5 YEARS (RANGE : 14-85 YEARS). PATIENTS WERE FOLLOWED TO COMPLETION OF WOUND HEALING IN ALL CASES, AND FOLLOW-UP AVERAGED 9.9 MONTHS. IN TWO PATIENTS (3 WOUNDS), THE INDICATION WAS FOR POST INFECTION SOFT TISSUE LOSS FOLLOWING RESOLUTION OF THE INFECTION ; IN ONE PATIENT AND ONE WOUND, FOR SOFT TISSUE LOSS ASSOCIATED WITH CHEMOTHERAPEUTIC EXTRAVASATION, ONE PATIENT/WOUND FOR SCLERODERMA AND EXPOSED PIP JOINT ; IN 23 WOUNDS FOR TRAUMATIC INDICATIONS, AND IN SIX PATIENTS/CASES FOR RECONSTRUCTION FOLLOWING EXCISION OF A MALIGNANCY. OF THESE PATIENTS, A SECOND STAGE PROCEDURE WAS PERFORMED IN 26 CASES, AT AN AVERAGE TIME POINT OF 25 DAYS FOLLOWING THE INITIAL PROCEDURE. THE SECOND STAGE PROCEDURE WAS A THIN FULL-THICKNESS SKIN GRAFT IN TWO CASES, A SPLIT THICKNESS SKIN GRAFT IN 24 CASES AND THE WOUND WAS ALLOWED TO GRANULATE IN OR HEAL BY SECONDARY INTENT IN FOUR CASES ; WHILE THE TWO PATIENTS (4 WOUNDS) WITH FAILURES HAD HEALING WITH DRESSING CHANGES AND NEGATIVE PRESSURE VACUUM ASSISTED WOUND CLOSURE (N = 1) OR ADDITIONAL PROCEDURES. THE OVERALL COMPLICATION RATE WAS 21% ; WITH A MAJOR COMPLICATION (FAILURE) RATE OF 6.9% (2 PATIENTS) AND A MINOR COMPLICATION RATE OF 13.8%. MAJOR COMPLICATIONS INCLUDED ONE PATIENT WHO WAS A SMOKER (3 SITES) WITH INFECTION AND FAILURE OF HIS DERMAL MATRIX BILAYER FOLLOWING HIS THERMAL BURN AND CRUSH INJURY FROM A MEAT PACKING PLANT INJURY; HE EVENTUALLY UNDERWENT ROTATIONAL AND FREE FLAPS WITH ADJUVANT USE OF DERMAL MATRIX BILAYERS, WHICH RESULTED IN FULL COVERAGE AND TAKE. ANOTHER PATIENT HAD FAILURE OF TAKE AND DEVELOPMENT OF SEVERE PAIN, DRAINAGE AND SOFT TISSUE SWELLING IN ONE PATIENT WITH BRACHYTHERAPY TO THE SITE DUE TO PRIMARY MALIGNANCY. MINOR COMPLICATIONS INCLUDED THE FOLLOWING : AN 83-YEAR-OLD MAN WITH DIABETES MELLITUS HAD PARTIAL FAILURE OF TAKE (85% TAKE) ; ONE PATIENT HAD DELAYED HEALING OF THE WOUND OVER THE TIBIA FOLLOWING APPLICATION OF THREE MONOLAYERS AND A BILAYER AFTER EXCISION OF AN OSTEOCHONDROMA ; ANOTHER PATIENT HAD A VENOUS BLEED UNDER THE DERMAL SUBSTITUTE RELATED TO HIS UNDERLYING TRAUMA AND DIGITAL REVASCULARIZATION. BECAUSE OF THE SMALL NUMBER OF COMPLICATIONS AND FAILURES IN THE SERIES, WE WERE UNABLE TO IDENTIFY STATISTICALLY SIGNIFICANT PREDICTORS OF FAILURE. THIS REPORT IS FOR ADVERSE EVENT - 72 YEAR OLD FEMALE - DELAYED HEALING OF THE WOUND OVER THE TIBIA FOLLOWING APPLICATION OF THREE MONOLAYERS AND A BILAYER AFTER EXCISION OF AN OSTEOCHONDROMA. WOULD TYPE: OSTEOCHONDROMA. SIZE: 5X7 CM. EXPOSED TISSUE: BONE. COMORBIDITIES: HYPERTENSION. %TAKE: 95%. ADDITIONAL PROCEDURE: SPLIT THICKNESS SKIN GRAFT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2232745 IDRT, UNKNOWN INTEGRA MDD INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male