BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 7478378 · Received May 1, 2018

    Report

    Report Number
    1030489-2018-00630
    Event Type
    Injury
    Date Received
    May 1, 2018
    Report Date
    May 1, 2018
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    UDI-DI
    00613994291004
    PMA / PMN Number
    K073291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. FOLLOWING PRODUCTS WERE ALSO REPORTED IN THE EVENT: NO. PRODUCT QTY LOT 510K 1 2991022 1 H5118852 K073291 00613994291004 3 7893050 1 0082307W K052609 00613994168894 4 7893060 1 0244750W K052609 00613994168917 5 7226550 3 NA K050809 00885074362915 6 7226535 1 NA K050809 00885074362885 7 7226545 1 NA K050809 00885074362908 8 7225545 1 NA K050809 00885074362762 ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    LEVEL: L3-L5 PROCEDURE: OPEN TRANSFORAMINAL INTERBODY FUSION IT WAS REPORTED THAT POST-OP, DURAL TEAR OCCURRED. SMALL PUNCTATE DURAL RENT OCCURRED JUST BELOW TAKE OFF OF L5 NERVE ROOT. DURAL TEAR WAS REPAIRED DURING INDEX SURGERY, SURGERY WAS ¿REPAIRED WITH 6-0 PROLENE SUTURE AND CLOSED WITH DURAGEN¿. PATIENT OUTCOME: RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321279 CAPSTONE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG NA H5118852 00613994291004

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R