BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEBRAL AUGMENTATION ACCESS KIT

    MDR report key: 6038056 · Received October 18, 2016

    Report

    Report Number
    3000270450-2016-10247
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    September 29, 2016
    Report Date
    September 29, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    KIH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART # 03.804.512S, LOT # AOR787. MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: OCT 13, 2014. EXPIRY DATE: AUG 01, 2019. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE 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

    PATIENT AGE REPORTED AS BETWEEN 50-60 YEARS OLD. ADDITIONAL DEVICE PRODUCT CODE: FZX, HXG, HTW, MJG (B)(4). DEVICE NOT IMPLANTED OR EXPLANTED, PARTIAL DEVICE REMAINED IN PATIENT. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, AS PARTIAL PART REMAINS IN THE PATIENT AND PARTIAL PART WAS DISCARDED BY THE FACILITY. (B)(6). A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE INITIAL SURGERY PERFORMED ON (B)(6) 2016 TO RESTORE VERTEBRA HEIGHT, THE WHITE INJECTION NEEDLE TOPS BROKE OFF AND REMAINED IN THE PATIENT. DURING THE PROCEDURE, AFTER THE SURGEON INSERTED THE TWO LARGE STENTS IN BOTH SIDES OF THE VERTEBRA, HE STARTED TO INJECT CEMENT VIA THE WHITE INJECTION NEEDLE. SURGEON SLIDE THE INJECTION NEEDLE INTO THE WORKING SLEEVES, NOT CERTAIN IF ASSEMBLED TOGETHER WITH THE CANNULATED TROCARS. HE INJECTED CEMENT AT ABOUT 5 TO 7 MINUTES AFTER CEMENT MIXED. HE FINISHED INJECTING THE CEMENT AT ABOUT 12 TO 15 MINUTES, AND ABOUT 6ML CEMENT INJECTED IN EACH SIDE. SURGEON THEN WAITED AND TRIED TO PULL OUT THE WHOLE ASSEMBLED INSTRUMENT AT ABOUT 20 MINUTES, BUT IT WAS STUCK. THE WHITE INJECTION NEEDLE TOPS BROKE OFF AND THE STAINLESS STEEL CANNULAS REMAINED IN THE PATIENT. SURGEON USED UNIVERSAL CHUNK TO REMOVE THE STAINLESS STEEL CANNULAE OF THE WHITE INJECTION NEEDLE. SURGEON REMOVED ALL THE EXPOSED CANNULA, HOWEVER SOME FRAGMENT TIPS REMAINED WITHIN THE CEMENT INSIDE THE VERTEBRA. THE FRAGMENT TIPS ARE LESS THAN 5MM AND 25MM ON BOTH SIDES. SURGERY WAS PROLONGED TO 60 MINUTES DUE TO REPORTED ISSUE. PATIENT CONDITION IMMEDIATELY AFTER THE EVENT WAS STABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT MEDICAL PRODUCTS: VERTECEM V+ CEMENT KIT (PART # 07.702.016S, LOT # 5E53130, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687910 VERTEBRAL AUGMENTATION ACCESS KIT DISPENSER, CEMENT KIH SYNTHES SELZACH AOR787

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ONE VERTECEM V+ CEMENT KIT