BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 6978955 · Received October 26, 2017

    Report

    Report Number
    1030489-2017-02249
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    September 27, 2017
    Report Date
    November 7, 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, HOWEVER, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES. FOLLOWING DEVICES WERE INVOLVED: PART# GX83565459 LOT# 0350269W QTY 1 SIMILAR DEVICE 83565459 510K# K090740 (B)(4). PART# GX83565459 LOT# 0490544W QTY 2 SIMILAR DEVICE 83565459 510K# K090740 (B)(4). PART# GX83565459 LOT# 0361972W QTY 1 SIMILAR DEVICE 83565459 510K# K090740 (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 83565459, 510K# K090740 AND (B)(4) IS APPROVED FOR SALE. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: L4 BURST FRACTURE PROCEDURE: L4: VERTEBROPLASTY; L3-5: POSTERIOR FUSION IT WAS REPORTED THAT POST-OP, CT EXAM REVEALED SCREW MALPOSITION AT L5. PATIENT SUFFERED WITH LOW BACK PAIN, LOWER EXTREMITY PAIN AND MUSCLE WEAKNESS AS A RESULT AND UNDERWENT A REVISION ON (B)(6) TO ADJUST THE POSITIONS OF THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761268 TSRH SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other| R RODS, CONNECTOR, SET SCREWS