BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 5339623 · Received January 1, 2016

    Report

    Report Number
    2953769-2016-00001
    Event Type
    Injury
    Date Received
    January 1, 2016
    Date of Event
    December 4, 2015
    Report Date
    January 13, 2016
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    NDN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PRODUCT ANALYSIS: REVIEW OF PRODUCT SPECIFICATION AND ASSOCIATED QAC DOES NOT REFERENCE AMPULE BREAKAGE PROCEDURE OR DESIGN INTENT OF AMPULE BREAKAGE. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY ADDITIONAL COMPLAINT RETURNS WITH THIS PART/LOT# COMBINATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT BALLOON KYPHOPLASTY PROCEDURE SURGERY FOR L1 COMPRESSION FRACTURE ON (B)(6) 2015. INTRA-OP, SCRUB NURSES CUT HIS/HER FINGER BY OPENED LID OF AMPLE WHEN THE NURSE WAS PREPARING LIQUID MONOMER FOR CEMENT MIXTURE. OTHER NURSE PROCEEDED THE SURGERY. THE EVENT WAS REPORTED BECAUSE BROKEN PATTERN MIGHT BE DIFFERENT FROM AS USUAL. IT CAUSED FINGER INJURY BUT THEY SEEMED TO THINK THAT THE BREAKAGE PATTERN OF AMPLE AFTER OPENING MIGHT BE DIFFERENT FROM AS USUAL NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG C01A-J EL50614

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Other