BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS KIT 4.7

    MDR report key: 6628981 · Received June 8, 2017

    Report

    Report Number
    3000270450-2017-10189
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    May 17, 2017
    Report Date
    May 17, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT ID AND DOB NOT PROVIDED FOR REPORTING. ADDITIONAL PRODUCT CODES: FZX MJG GEA HXG HTW KIH. (B)(4) LOT UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SPINAL FUSION ON (B)(6) 2017 THE JAMSHIDI NEEDLE PERFORATED THE AORTA. VASCULAR SURGEONS TOOK OVER THE PROCEDURE AND MANAGED THE PROBLEMS. THE SURGERY WAS PROLONGED TO AN UNKNOWN TIME. THE PATIENT WAS AFTER THE EVENT, UNSTABLE AND LATER PATIENT WAS STABLE. THIS COMPLAINT INVOLVES 1 PART. THE SURGERY WAS DELAYED AS THEY COULD NOT CONTINUE. A SECOND SURGERY IS PLANNED. THE ISSUE WAS SOLVED BY THE VASCULAR SURGEONS. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409617 ACCESS KIT 4.7 MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention