BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEKSELL RONG 9 SLIGHT-CVD 8MM

    MDR report key: 16078867 · Received December 30, 2022

    Report

    Report Number
    3014334038-2022-00288
    Event Type
    Malfunction
    Date Received
    December 30, 2022
    Date of Event
    November 22, 2022
    Report Date
    January 31, 2023
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    HTX
    UDI-DI
    10381780382775
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE LEKSELL RONG 9 SLIGHT-CVD 8MM (230261) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. THE LEKSELL RONG WAS RECEIVED IN USED CONDITION WITH THE TIP OF ONE OF THE JAWS BROKEN DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. THE PRODUCT LOT NUMBER INDICATES A MANUFACTURE DATE OF 2013. THE BREAKAGE MAY HAVE BEEN THE RESULT OF DAMAGE OVER TIME. THE REPORTED COMPLAINT WAS CONFIRMED. NO MANUFACTURING, WORKMANSHIP OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.

    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.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DOCTOR WAS USING THE LEKSELL RONG 9 SLIGHT-CVD 8MM (230261) "INSIDE PATIENT WHEN ONE SIDE OF BITE BROKE OFF. A SMALL PIECE OF METAL WAS RECOVERED BUT DOESN'T LOOK LIKE THE FULL PIECE THAT BROKE OFF. CHECKED ALL RAYTEC FOR ANY ADDITIONAL METAL, NONE FOUND, HAD XRAY TAKE PICTURES AND SENT TO RADIOLOGY TO SEE IF ANY METAL CAN BE FOUND AND CONFIRMED WITH CELL SAVER THAT IF PIECE OF METAL WAS SUCKED UP THAT IT WOULD BE STOPPED AT FILTER WHEN BLOOD WAS SPUN DOWN. OR MANAGER CALLED INTO ROOM, AND INSTRUMENT AND PIECE OF METAL TAKEN TO RISK MANAGEMENT BY OR MANAGER." IT WAS REPORTED THAT NOT ALL BROKEN PARTS WERE RECOVERED; ONLY A SMALL FRAGMENT WAS RECOVERED. PER STAFF, NO ADDITIONAL FRAGMENTS WERE FOUND IN RAYTEC AND NO FRAGMENTS WERE VISIBLE VIA X-RAY. X-RAY FINDINGS DETERMINED OPERATIVE CHANGES FOLLOWING LUMBOSACRAL FUSION WITHOUT UNEXPECTED FINDINGS. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION, WITH NO DETECTABLE HARM RESULTING FROM THE INCIDENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2022, WITH NO KNOWN PROCEDURAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453002 LEKSELL RONG 9 SLIGHT-CVD 8MM N/A HTX INTEGRA LIFESCIENCES MANSFIELD 230261 56-1302 10381780382775

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown