BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6731132 · Received July 21, 2017

    Report

    Report Number
    1030489-2017-01809
    Event Type
    Injury
    Date Received
    July 21, 2017
    Report Date
    June 27, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT IS UNKNOWN WHICH OF THE DEVICES LED TO THE EVENT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES. FOLLOWING DEVICES WERE INVOLVED: PART# LOT# 5431414, (B)(4). 5431415, (B)(4). PMA 510(K): ABOVE MENTIONED PARTS ARE NOT APPROVED FOR USE IN THE US, HOWEVER LIKE DEVICES WITH PART# 5531414 (510K# K150178 AND UPN (B)(4) AND 5531415 (510K# K150178 AND UPN (B)(4)) IS APPROVED FOR THE US MARKET. (B)(4). 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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS:SPINAL CANAL STENOSIS, PSEUDARTHROSIS PROCEDURE: POSTERIOR FUSION LEVELS IMPLANTED: T9-L1 IT WAS REPORTED THAT ON UNKNOWN DATE, POST-OP, THE VERTEBRAL COLLAPSE AT T11 PROGRESSED AND THE SCREWS BACKED OUT AT T9-T10. BACK PAIN DEVELOPED IN THE PATIENT DUE TO THORACIC KYPHOSIS. REVISION SURGERY WAS PERFORMED FOR REMOVAL OF THE IMPLANTS AND EXTENSION OF THE FIXATION RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513901 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other| R