BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10739004 · Received October 27, 2020

    Report

    Report Number
    1030489-2020-01488
    Event Type
    Injury
    Date Received
    October 27, 2020
    Report Date
    October 27, 2020
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH DAMAGE IN PATIENT; LOWER LIMB SYMPTOMS. REPORT SOURCE: FOREIGN: (B)(6); SIMILAR DEVICES 510(K) #: K201407, K202328, K201362. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH STENOSIS ON L5 SUGGESTED FOR SPINAL THERAPY. EVENT OCCURRED DURING USE OF THE IMPLANT. PLIF WAS PERFORMED ON L2-5 ON (B)(6) 2012. ON (B)(6) 2014, IMPLANT ON L2-5 WAS REMOVED AND FUSION WAS PERFORMED ON T12-L5. ON (B)(6) 2014, FUSION WAS EXTENDED TO 9-10-11. ON (B)(6) 2017, IMPLANT ON T9, 10, 11 WAS REMOVED AND FUSION WAS EXTENDED TO T6-7-8. IT WAS REPORTED THAT THERE WAS LOWER LIMBS SYMPTOM OCCURRED ON L5. REVISION SURGERY WAS PERFORMED. PLIF WAS PERFORMED ON L5-S1. IMPLANT REMAINS IN PATIENT. HEALTH DAMAGE IN PATIENT REPORTED. NO FURTHER SYMPTOMS OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203691 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG 54740008550 H11H4052

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other| R