BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFLATE BALLOON/SMALL-STERILE

    MDR report key: 4788001 · Received May 21, 2015

    Report

    Report Number
    3000270450-2015-10108
    Event Type
    Malfunction
    Date Received
    May 21, 2015
    Date of Event
    April 29, 2015
    Report Date
    April 29, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRX
    PMA / PMN Number
    PK130146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE:(B)(4). 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 DEVICE PRODUCT CODE - NDN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). A 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 EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT TWO SYNFLATE BALLOON DEVICES BURST/WERE DAMAGED DURING REMOVAL. DURING A SPINAL PROCEDURE TO TREAT FRACTURES AT THORACIC VERTEBRAE LEVELS 6-7 AND LUMBAR VERTEBRAE LEVEL 3, BOTH SYNFLATE DEVICES REPORTEDLY OPERATED VERY WELL FOR ALL THREE VERTEBRAE. AFTER EXPLANTATION OF THE SYNFLATE THE SURGEON REALIZED THAT BLOOD WAS IN THE SYNFLATE SYSTEM. THE SURGEON WAS SURPRISED TO SEE THAT THE SYNFLATE BURST, BECAUSE ACCORDING TO THE X-RAYS THE BALLOON WAS IN A PERFECT SHAPE. AFTER THE SURGERY THE SURGEON ANALYSED THE SYNFLATE AND REALIZED THAT BOTH SYNFLATES WERE BROKEN. ACCORDING TO THE OBSERVATION BOTH BALLOONS WERE DAMAGED DURING THE REMOVAL PROCESS THROUGH THE ACCESS KIT. THE BURSTING OF THE SYNFLATES HAD NO ADVERSE EFFECT ON THE SURGERY OR THE PATIENT. THE SURGERY ENDED WITH EXCELLENT RESULT FOR THE PATIENT. THERE WAS NO SURGICAL DELAY. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331454 SYNFLATE BALLOON/SMALL-STERILE ACCESSORIES, ARTHROSCOPIC HRX SYNTHES SELZACH 103002

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR