BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WINCH KYPHOPLASTY KIT 15MM

    MDR report key: 19589577 · Received June 21, 2024

    Report

    Report Number
    3010899956-2024-00002
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Report Date
    June 14, 2024
    Manufacturer
    G21 S.R.L.
    Product Code
    NDN
    PMA / PMN Number
    K172214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BEING AN ASSEMBLED KIT, THE MEDICAL DEVICES THAT MAKE UP THE 900016 BATCH 20231100033 ARE AS FOLLOWS: 1. 900027 WINCH KYPHOPLASTY BALLOON CATHETER 11 G 15 MM LOT20230500073 2. 900103 KEYFIX_DIRECT ACCESS NEEDLE LOT 20230900080 3. 900103 KEYFIX_DIRECT ACCESS NEEDLE LOT 20231000126 4. 900141 KEYFIX BONE DRILL LOT 20230900008 5. 900097 KEYFIX_BONE CEMENT FILLER CANNULA LOT 20230400052 6. K05-02919 G21 KYPHOPLASTY DIGITAL INFLATION DEVICE LOT H2622146 A REVIEW OF THE PRODUCTION DHR HAS BEEN PERFORMED FOR THE PRODUCT. NO NONCONFORMITIES HAVE BEEN IDENTIFIED DURING PRODUCTION. NO COMPLAINTS CONCERNING KITS CONTAINING DEVICE 900027 BATCH 20230500073 WERE RECEIVED FROM IDENTIFIED CUSTOMERS. INFORMATION PROVIDED BY THE CLIENT STATED, "THE PATIENT WAS INVOLVED, THE BALLOON EXPLODED DURING THE INFLATION PROCEDURE TO LIFT THE CRUSHED VERTEBRA AND THE CONTRAST SPILLED INTO THE VERTEBRA OF THE PACT DUE TO THE EXPLOSION OF THE BALLOON DURING INSUFFLATION. THE SURGICAL PLAN COULD NOT BE FULFILLED. THE SYSTEM HAD TO BE CHANGED TO A VERTEBROPLASTY. THE PATIENT WAS PREPARED ACCORDING TO ESTABLISHED STANDARDS FOR THIS PROCEDURE, SURGEON HAS EXPERIENCE IN THIS TYPE OF SURGICAL PROCEDURE, AND THE HOSPITAL WHERE THE SURGERY WAS PERFORMED IS A RECOGNIZED AND REFERENCED HOSPITAL THAT PERFORMS THIS TYPE OF PROCEDURE REGULARLY." IT IS REPORTED THAT THE PATIENT WAS AFFECTED BY THE EVENT BECAUSE THE SURGICAL PLAN WAS NOT FULFILLED, AS PER PROVIDED INFORMATION THERE'S NO INDICATION OF ANY HARM OCCURRED TO THE PATIENT BECAUSE OF THE NON-FULFILLMENT OF THE KYPHOPLASTY SURGICAL PLAN. NO COMPLAINTS CONCERNING KITS CONTAINING THE DEVICE 900027 BATCH 20230500073 HAVE BEEN RECEIVED. TWO COMPLAINTS HAVE BEEN RECEIVED IN PAST YEARS CONCERNING THE BURSTING OF DEVICE 900027: · COMPLAINT N°(B)(4). THE REVIEW OF THE DFMECA# B002_12 SHOWN THAT THERE IS NO NEED TO RAISE THE RISK OR INSERT A NEW RISK BASED ON THE FOLLOWING CONSIDERATIONS: · THE NUMBER OF DEVICES MANUFACTURED IN THE BATCH 20231100033 IS 435 AND ONLY ONE DEVICE FROM THE SAME BATCH IS INVOLVED IN THIS COMPLAINT. · THIS IS THE ONLY ONE COMPLAINT RECEIVED FOR THIS BATCH · THIS IS THE THIRD COMPLAINT EVER AND THE FIFTH DEVICE, SINCE PRODUCT 900027 WAS MARKETED IN 2016, FOR THIS TYPE OF FAILURE MODE. · THE OCCURRENCE OF THIS FAILURE MODE FOR THIS BATCH IS <1%. · THE OCCURRENCE OF THIS FAILURE MODE RESPECTS THE TOTAL NUMBER OF DEVICES SOLD SINCE PLACING ON THE MARKET IS <0.05% CONCLUSION: BASED ON THE ABOVE INVESTIGATION AND RISK ANALYSIS WITH THE AVAILABLE INFORMATION OF THE COMPLAINT, IT IS CONCLUDED THAT THE RISK TO THE PATIENT AND THE DEVICE IS DEEMED TO BE LOW.

    Description of Event or Problem · 0

    THE PROCEDURE IS FOLLOWED: KYPHOPLASTY BALLOON IS PLACED, BUT WHEN THE SYSTEM IS INFLATED, THE BALLOON BURSTS, SPILLING THE CONTRAST INTO THE VERTEBRAL BODY. BALLOON FAILURE SINCE WE WERE UNABLE TO INFLATE MORE THAN 80 PSI AND THE BALLOON BURST AND LEAKED THE CONTRAST INTO THE VERTEBRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156953 WINCH KYPHOPLASTY KIT 15MM CEMENT, BONE, VERTEBROPLASTY NDN G21 S.R.L. 900016 20231100033

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention