BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRT, UNKNOWN

    MDR report key: 14982637 · Received July 11, 2022

    Report

    Report Number
    1121308-2022-00056
    Event Type
    Malfunction
    Date Received
    July 11, 2022
    Report Date
    August 16, 2022
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    MDD
    PMA / PMN Number
    P900033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    IDRT SAMPLE 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. THE ROOT CAUSE OF ANY CITED ADVERSE EVENT IN THE LITERATURE IS UNDETERMINED. HOWEVER, THE MOST PROBABLE ROOT CAUSE IS MOST LIKELY ATTRIBUTABLE TO THE POSTOPERATIVE CARE PROVIDED TO 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

    THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 1121308-2022-00057 PLASTIC AND RECONSTRUCTIVE SURGERY (2021) PUBLISHED; "SCALP RECONSTRUCTION AFTER MOHS CANCER EXCISION: LESSONS LEARNED FROM MORE THAN 900 CONSECUTIVE CASES". BACKGROUND: SCALP RECONSTRUCTION HAS EVOLVED OVER TIME. GIVEN THE LARGE SURFACE AREA, LOCATION, AND HIGH LIKELIHOOD OF SUN EXPOSURE, THE SCALP IS PARTICULARLY PRONE TO SUN DAMAGE AND SKIN CANCER. RESECTION OF SCALP CANCERS OFTEN LEAVES A LARGE DEFECT THAT CAN BE CHALLENGING FOR RECONSTRUCTION. THE AUTHORS PRESENT OBJECTIVE DATA AND RECOMMENDATIONS BASED ON MORE THAN 10 YEARS OF CONSECUTIVE SCALP RECONSTRUCTIONS PERFORMED BY THE SENIOR AUTHOR (J.F.T.). IN ADDITION, THE AUTHORS DESCRIBE EACH METHOD OF RECONSTRUCTION AND DELINEATE AN ALGORITHM BASED ON THE SENIOR AUTHOR¿S APPROACH AND THE CASES ASSESSED. METHODS: THE AUTHORS CONDUCTED A RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT SCALP RECONSTRUCTION AFTER MOHS CANCER EXCISION OVER A 10-YEAR PERIOD. EACH CASE WAS EVALUATED FOR KEY PATIENT CHARACTERISTICS, DEFECT LOCATION, DEFECT SIZE, DEFECT COMPOSITION, RECONSTRUCTIVE MODALITY, AND COMPLICATIONS. RESULTS: THE SENIOR AUTHOR (J.F.T.) PERFORMED 913 SCALP RECONSTRUCTION PROCEDURES. DEFECTS MOST COMMONLY INVOLVED THE FOREHEAD OR VERTEX OF THE SCALP, WITH A WIDE RANGE OF SIZES. A SIGNIFICANT MAJORITY OF THE PATIENTS¿ DEFECTS WERE REPAIRED WITH THE USE OF ADJACENT TISSUE TRANSFER OR INTEGRA DERMAL REGENERATION TEMPLATES. THERE WERE 94 COMPLICATIONS (12.5 PERCENT) NOTED, RANGING FROM GRAFT LOSS TO CANCER RECURRENCE. MALFUNCTIONS: INTEGRA LOSS 14 (1.9) COMPLETE 10 (1.3) PARTIAL 4 (0.5). ALMOST ONE THIRD (N = 299) USED INTEGRA (INTEGRA LIFESCIENCES CORP., PRINCETON, N.J.), WHICH WAS MOST COMMONLY FOLLOWED BY SPLIT-THICKNESS SKIN GRAFT PLACEMENT. OF THE RECONSTRUCTIVE PROCEDURES, 172 INVOLVED BONE BURRING BEFORE PLACEMENT OF INTEGRA OR AUTOLOGOUS SKIN GRAFT. THE NEXT MOST FREQUENT RECONSTRUCTIVE MODALITIES WERE SKIN GRAFT ALONE, COMPLEX CLOSURE, AND USE OF OTHER ACELLULAR DERMAL MATRICES. LESS COMMON MODALITIES INCLUDED SECONDARY HEALING AND USE OF A FREE FLAP. FIVE OF THE CASES REQUIRED TISSUE EXPANSION TO ACHIEVE FINAL HAIR-BEARING COVERAGE. CONCLUSIONS: RECONSTRUCTION OF SCALP DEFECTS AFTER MOHS CANCER EXCISION PRESENTS THE PLASTIC SURGEON WITH NUMEROUS PATIENT AND DEFECT PREOPERATIVE VARIABLES TO CONSIDER. EACH DEFECT SHOULD BE EVALUATED, AND A PLAN BASED ON COMPOSITION OF THE DEFECT AND THE NEEDS OF THE PATIENT SHOULD BE DEVELOPED. SCALP RECONSTRUCTION IS SAFE TO PERFORM IN AN OUTPATIENT SETTING, EVEN IN ELDERLY PATIENTS. DOI: 10.1097/PRS.0000000000007884.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014262 IDRT, UNKNOWN INTEGRA MDD INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown