BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

    MDR report key: 7141910 · Received December 22, 2017

    Report

    Report Number
    1030489-2017-02556
    Event Type
    Injury
    Date Received
    December 22, 2017
    Report Date
    December 22, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: PRODUCT ID: QTY: SIMILAR PART: 510K# UPN UNKNOWN; SCREW, 1, NA, NA, NA, G8292035, 4, 8292035, K031967. 00721902947896 G8699045, 1, NA, K981676, 00613994271846. 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 PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L4/L5. POST-OP, ADJACENT SEGMENTAL DISORDER WAS DEVELOPED AT THE CRANIAL SIDE OF L4/5 AREA. A REVISION SURGERY (PLIF SURGERY) IS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922209 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R