BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE CONTROL SPINAL SYSTEM

    MDR report key: 9731371 · Received February 20, 2020

    Report

    Report Number
    1030489-2020-00179
    Event Type
    Injury
    Date Received
    February 20, 2020
    Date of Event
    December 1, 2019
    Report Date
    February 20, 2020
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    K120368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: PRODUCT ID: 4011122, LOT: 52CU(X1), UDI: (B)(4). PRODUCT ID: 4011222, LOT: 22EY(X1); H5396795(X1), UDI: (B)(4). ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) OF 3 INTERVERTEBRAL DISCS (L3/4/5/S) DUE TO LUMBAR SPINAL STENOSIS (LSS). POST-OP, THERE WAS PUS AROUND THE IMPLANTS. IT WAS UNKNOWN THAT AROUND WHICH IMPLANT THE INFECTION OCCURRED. THE PATIENT UNDERWENT REVISION SURGERY AS A RESULT OF THIS EVENT. ALL THE IMPLANTED DEVICES HAVE BEEN REMOVED. THERE WERE NO MALFUNCTION WITH THE ALLEGED IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195904 CAPSTONE CONTROL SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG NA SEE-H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other