BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 13677978 · Received March 7, 2022

    Report

    Report Number
    1030489-2022-00212
    Event Type
    Injury
    Date Received
    March 7, 2022
    Report Date
    March 7, 2022
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SET SCREW BACK OUT INVOLVED IN THE SPINE RE-FIXATION PROCEDURE. LEVELS IMPLANTED: L1-S2. IT WAS REPORTED THAT POST-OPERATIVELY, THE SET SCREW OF THE S2AI SCREW BACKED OUT. PRODUCT WAS USED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. EVENT WAS REVISION SURGERY. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR OVER 60 MINUTES. INITIAL SURGERY DETAILS- SIMULTANEOUS ANTERIOR-POSTERIOR FUSION WAS PERFORMED IN THE OPERATION PERFORMED ON (B)(6) 2019, AND FIXATION WAS EXTENDED ON (B)(6) 2021. SET SCREW BACK OUT OCCURRED, SO REFIXATION WAS PERFORMED. ON (B)(6) 2022, RECEIVED ADDITIONAL INFORMATION THAT PATIENT SYMPTOMS ARE UNKNOWN. ON (B)(6) 2022, RECEIVED UPDATED INFORMATION THAT AFTER THE INITIAL SURGERY ((B)(6) 2019), THE PATIENT SUFFERED AN ADJACENT SEGMENT DISEASE, LEADING TO RE-SURGERY. CLYDESDALE PTC / VOYAGER 4.75 WAS USED AT THE TIME OF THE INITIAL SURGERY, BUT VOYAGER 4.75 WAS REMOVED AND REPLACED WITH VOYAGER 5.5 / 6.0 AT THE TIME OF RE-SURGERY ON (B)(6) 2021. THERE WAS A FEELING OF CROSS-THREADING WHEN INSERTING THE SET SCREW OF THE RE-SURGERY. ON (B)(6) 2022, RECEIVED ADDITIONAL INFORMATION THAT LEVELS IMPLANTED IN THE INITIAL SURGERY- L1-L5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1962320 CD HORIZON® SPINAL SYSTEM NKB MDT SOFAMOR DANEK PUERTO RICO MFG MSB_UNK_VOY_IMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention