BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFLATE BALLOON/SMALL-STERILE

    MDR report key: 4784702 · Received May 20, 2015

    Report

    Report Number
    3000270450-2015-10106
    Event Type
    Malfunction
    Date Received
    May 20, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 28, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    NDN
    PMA / PMN Number
    PK130146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT WEIGHT WAS NOT PROVIDED BY REPORTER. ADDITIONAL DEVICE PRODUCT CODE- NDN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SYNFLATE BURST IN SITU DURING A SURGICAL PROCEDURE TO TREAT A FRACTURE AT THORACIC VERTEBRA LEVELS 10/11. THE DEVICE REPORTEDLY BEEN FILLED ACCORDING TO THE PRESSURE/ML INDICATIONS PER THE SYNFLATE MANUAL. ANOTHER SYNFLATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT¿S OUTCOME WAS REPORTED AS ¿EXCELLENT.¿ THE SURGERY WAS DELAYED BY APPROXIMATELY THREE MINUTES DUE TO THE REPORTED EVENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330501 SYNFLATE BALLOON/SMALL-STERILE ACCESSORIES, ARTHROSCOPIC NDN SYNTHES SELZACH 1013002

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR