BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1030489-2017-00542

    MDR report key: 6405065 · Received March 15, 2017

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    1030489-2017-00542
    Event Type
    Injury
    Date Received
    March 15, 2017
    Date of Event
    February 16, 2015
    Report Date
    February 16, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: X-RAY REVIEW: POST-OP CT FOR L1-3 MID-LINE CONSTRUCT FIXATION PROCEDURE. THERE IS A LOSS OF LUMBAR LORDOSIS AND L2-3 INSTRUMENTATION APPEARS TO BE BACKED OUT. GIVEN SAGITTAL BALANCE AND LEVELS OF INSTRUMENTATION, THIS CONSTRUCT WAS LIKELY INADEQUATE FROM A B IO-MECHANICAL STAND POINT. ROOT CAUSE: SURGICAL TECHNIQUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS (INITIAL SURGERY): SPINAL CANAL STENOSIS, HERNIATION PROCEDURE (INITIAL SURGERY): CORTICAL BONE TRAJECTORY (CBT), POSTERIOR LUMBAR FUSION (PLF) LEVELS (INITIAL SURGERY): L1/2/3 IT WAS REPORTED THAT ON (B)(6) 2013, PATIENT UNDERWENT CORTICAL BONE TRAJECTORY (CBT), AND POSTERIOR LUMBAR FUSION (PLF) SURGERY. POST-OP, LOOSENING OF SCREW WAS REPORTED AT THE PERFORMED CORTICAL BONE TRAJECTORY AT L3 AND L1/2. PATIENT COMPLAINED OF LOW BACK PAIN AND NUMBNESS OF LOWER LIMBS. PATIENT UNDERWENT A REMOVAL AND RE-FIXATION SURGERY DUE TO RECURRENT HERNIATION OF THE FIXATION PART AT L2/3 IN WHICH SCREWS WERE EXPLANTED. THE PATIENT ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188328 HWC MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R