BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

    MDR report key: 6957294 · Received October 18, 2017

    Report

    Report Number
    1030489-2017-02225
    Event Type
    Injury
    Date Received
    October 18, 2017
    Report Date
    October 18, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    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

    ALTHOUGH IT IS UNKNOWN IF THE DEVICES LED TO THE EVENT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES. FOLLOWING DEVICES WERE INVOLVED: PART# 54740005530, LOT# H5377612, QUANTITY-2. THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 54840 005530, 510K# K091974, AND UDI (B)(4) IS APPROVED FOR MARKET IN THE US. PART# 54740005535, LOT# H5380203, QUANTITY-2. THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 54840 005535, 510K# K091974, AND UDI (B)(4) IS APPROVED FOR MARKET IN THE US. PART# 54740007545, LOT# H5334481, QUANTITY-1. THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 54840 007545, 510K# K091974, AND UDI (B)(4) IS APPROVED FOR MARKET IN THE US. PART# 54740007545, LOT# H5365016, QUANTITY-1. THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 54840 007545, 510K# K091974, AND UDI (B)(4) IS APPROVED FOR MARKET IN THE US. PART# 3992210, LOT# H5244227, QUANTITY-1, 510K# K172199, AND UDI (B)(4). PART# 3992210, LOT# H5299892, QUANTITY-1, 510K# K172199, AND UDI (B)(4). PART# 3992211, LOT# H5226840, QUANTITY-1, 510K# K172199, AND UDI (B)(4). PART# 3992211, LOT# H5281931, QUANTITY-1, 510K# K172199, AND UDI (B)(4). PART# 7068396, LOT# H5350976, QUANTITY-1. THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 5440030, 510K# K102555, AND UDI (B)(4) IS APPROVED FOR MARKET IN THE US. PART# 7600105, LOT# 213086499, QUANTITY-2, 510K# K082917, AND UDI (B)(4). PART# G9010001425, LOT# H5280221, QUANTITY-1, 510K# K153589, AND UDI (B)(4). PART# 5430030, LOT# H5343087, QUANTITY-2. THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 5440030, 510K# K102555, AND UDI (B)(4) IS APPROVED FOR MARKET IN THE US. PART# 5432025, LOT# 0278157W, QUANTITY-1. THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 5442025, 510K# K091974, AND UDI (B)(4) IS APPROVED FOR MARKET IN THE US. PART# 1475101050, LOT# 0503286W, QUANTITY-2. THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 1475001050, 510K# K091974, AND UDI (B)(4) IS APPROVED FOR MARKET IN THE US. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION SURGERY (TLIF) AT L4-L5, L5-S; COGNITIVE BEHAVIORAL THERAPY (CBT) AT L4-L5; SCREWS PLACEMENT AT S1. POST-OP, COMPRESSION FRACTURE AT T12-L1 AND LUMBAR SPINAL CANAL STENOSIS AT L1-2 WERE OBSERVED. REVISION WAS SCHEDULED TO BE PERFORMED ON (B)(6) 2017. PATIENT DEVELOPED FEVER AND INFECTION WAS SUSPECTED AT THE NIGHT BEFORE THE REVISION SURGERY. REVISION STARTED AS SCHEDULED ON (B)(6) 2017. DURING REVISION SURGERY, PUS CAME OUT FROM THE PART THAT WAS PERFORMED IN INITIAL SURGERY WHICH MADE SURGEON DETERMINE POST-OP INFECTION AT L4-S AND THE PROCEDURE WAS CHANGED AND WASHING WAS PERFORMED. NO MALFUNCTIONS WERE REPORTED AGAINST ANY OF THESE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736715 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention