BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURG PAT XRAY 1/2X1 1/2

    MDR report key: 20078374 · Received August 27, 2024

    Report

    Report Number
    3014334038-2024-00178
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 5, 2024
    Report Date
    September 20, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    HBA
    UDI-DI
    10381780515005
    PMA / PMN Number
    K880402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11. THE SURGICAL PATTIE (B)(6) WAS NOT RETURNED FOR EVALUATION AS THE PRODUCT IS NOT AVAILABLE FOR RETURN AS PER CUSTOMER. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, A PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT MAY BE RELATED TO INADEQUATE WELD STRENGTH OF THE STRING TO THE PATTIE'S SURFACE. 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. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS CLOSED IN AUGUST 2024 FOR THE PATTIES/STRIPS PRODUCT FAMILY RELATED TO X-RAY POLYMER ISSUES, STRING ISSUES AND INCORRECT COUNT. ACTIONS WERE IMPLEMENTED TO MINIMIZE THE ISSUES ABOVE.

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED THE SURGICAL PATTIE (ID 801404) STRING WAS LOST DURING A SURGERY (POSTERIOR BILATERAL LUMBAR DECOMPRESSION AT L2-5). THE WOUND WAS IRRIGATED AND THOROUGHLY SEARCHED. THE ROOM, DRAPES, GOWNS, BACK TABLE, AND TRASH CONTAINERS WERE ALSO INSPECTED. THE PATTIES WERE MOISTENED FOR AN HOUR AND WAS NOT ALTERED OR CUT FROM ORIGINAL SIZE PRIOR TO USE. THE PATTIES WERE SOAKED DURING USE. AN X-RAY WAS TAKEN TO ENSURE THAT THE STRING WAS NOT INSIDE THE PATIENT. THE EVENT DID NOT LED TO A SIGNIFICANT SURGICAL DELAY, AND AS OF RIGHT NOW, NO ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521118 SURG PAT XRAY 1/2X1 1/2 SURGICAL PATTIES HBA INTEGRA LIFESCIENCES MANSFIELD 6561126 10381780515005

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male