BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE 1352282 O/R TABLE BRACKET

    MDR report key: 13742964 · Received March 12, 2022

    Report

    Report Number
    3014334038-2022-00048
    Event Type
    Malfunction
    Date Received
    March 12, 2022
    Date of Event
    February 17, 2022
    Report Date
    March 25, 2022
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    FXG
    UDI-DI
    10381780074533
    PMA / PMN Number
    EXEMPT
    Product Problem
    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

    THE BLADE O/R TABLE BRACKET (1352282) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS - EVALUATION WAS UNABLE TO CONCLUSIVELY VERIFY CUSTOMER INFORMATION AS VALID. THE BRACKET WAS UNDAMAGED AND NO DEFECT WAS FOUND. TESTING WAS WITHIN SPECIFICATION. ROOT CAUSE - THE RETURNED 1352282 TABLE BRACKET IS IN USED CONDITION WITH NO VISIBLE DEFECT. THE BRACKET WAS IN USE WITH A BROKEN 1352275 SPECULUM ARM. THE ARM IS BEING INVESTIGATED UNDER A SEPARATE COMPLAINT. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.

    Description of Event or Problem · 0

    THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3014334038-2022-00049, 3014334038-2022-00050. A FACILITY REPORTED THAT THE BLADE O/R TABLE BRACKET (1352282) BROKE IN THE MIDDLE OF A TYMPANOPLASTY PROCEDURE. ALL PARTS WERE RECOVERED AND WERE TAKEN OFF THE SURGICAL FIELD; NO FRAGMENTS FELL INTO THE SURGICAL SITE. IT WAS REPORTED THAT AN X-RAY WAS PERFORMED TO ASSURE THAT NO PARTS WERE LEFT IN THE PATIENT FOLLOWING THE EVENT. THE EVENT DID NOT LEAD TO PATIENT INJURY, DEATH, OR DELAY IN PROCEDURE.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150052 BLADE 1352282 O/R TABLE BRACKET PFM11 FXG INTEGRA LIFESCIENCES MANSFIELD 1352282 10381780074533

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown