BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFLATE BALLOON/SMALL- STERILE

    MDR report key: 6520912 · Received April 25, 2017

    Report

    Report Number
    3000270450-2017-10142
    Event Type
    Malfunction
    Date Received
    April 25, 2017
    Date of Event
    April 4, 2017
    Report Date
    April 4, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRX
    PMA / PMN Number
    K130146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. ADDITIONAL PRODUCT CODE: NDN. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    LOT, EXPIRATION DATE, AND UDI: (B)(4). MANUFACTURING LOCATION: (B)(4). SUPPLIER: (B)(4). MANUFACTURING DATE: NOVEMBER 04, 2016. EXPIRY DATE: SEPTEMBER 30, 2018. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT IS REPORTED DURING A KYPHOPLASTY PROCEDURE AT T11, T12, AND L1 ON (B)(6) 2017, THREE (3) SYNFLATE BALLOONS BROKE. THE BALLOONS INFLATED SUCCESSFULLY AND THEN BROKE. A COMPETITOR¿S BALLOON WAS USED ON ONE OR TWO OF THE LEVELS TO COMPLETE THE PROCEDURE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY TEN (10) MINUTES TO OBTAIN ADDITIONAL BALLOONS. SURGEON WAS SATISFIED WITH THE PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) SYNFLATE BALLOON. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301925 SYNFLATE BALLOON/SMALL- STERILE ACCESSORIES, ARTHROSCOPIC HRX SYNTHES SELZACH 0916012

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR