BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    MDR report key: 4921179 · Received July 17, 2015

    Report

    Report Number
    1030489-2015-01494
    Event Type
    Injury
    Date Received
    July 17, 2015
    Report Date
    June 19, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION:XIN-LEI XIA, HONG-LI WANG, FEI-ZHOU LYU, LI-XUN WANG, XIAO-SHENG MA, JIAN-YUAN JIANG; "MAST QUADRANT-ASSISTED MINIMALLY INVASIVE MODIFIED TRANSFORAMINAL LUMBAR INTERBODY FUSION: SINGLE INCISION VERSUS DOUBLE INCISION". MEAN AGE:56.0 ± 13.5 (SINGLE INCISION), MEAN AGE: 54.8 ± 12.7 (DOUBLE INCISION). MALE-18, FEMALE:16 (SINGLE INCISION), MALE-21, FEMALE:16 (DOUBLE INCISION). MEAN WEIGHT:68.3 ± 8.2(SINGLE INCISION), MEAN WEIGHT:70.3 ± 7.7(DOUBLE INCISION). (B)(6). (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.

    Description of Event or Problem · 1

    THIRTY-FOUR PATIENTS WITH SINGLE SEGMENTAL LUMBAR DEGENERATIVE DISEASE (18 MALES AND 16 FEMALES) FOR WHOM CONSERVATIVE TREATMENT WAS INEFFECTIVE UNDERWENT MINIMALLY INVASIVE MODIFIED TLIF. THE MAST QUADRANT-ASSISTED OPERATION WITH A SMALL SINGLE POSTERIOR MEDIAN INCISION WAS PERFORMED IN THE SINGLE INCISION GROUP. PATIENTS IN THIS GROUP WERE COMPARED TO THE 37 PATIENTS WITH SINGLE-SEGMENT DEGENERATIVE LUMBAR DISEASE IN THE DOUBLE INCISION GROUP WHO RECEIVED THE MAST QUADRANT-ASSISTED MINIMALLY INVASIVE MODIFIED TLIF WITH A DOUBLE PARAMEDIAN INCISION BETWEEN JUNE 2010 AND FEBRUARY 2011. THE AVERAGE AGE AND AVERAGE WEIGHT OF PATIENTS IN THE SINGLE INCISION GROUP WERE 56.0 ± 13.5 YEARS AND 68.3 ± 8.2 KG, RESPECTIVELY, AND THE AVERAGE AGE AND AVERAGE WEIGHT OF PATIENTS IN THE DOUBLE INCISION GROUP WERE 54.8 ± 12.7 YEARS AND 70.3 ± 7.7 KG, RESPECTIVELY. HAVE EXCISED AUTOLOGOUS BONE GRAFT WHICH WAS TRIMMED TO BONE PARTICLES OF AN APPROPRIATE SIZE AND WAS IMPLANTED INTO THE ANTERIOR DISC SPACE. AN INTERVERTEBRAL FUSION DEVICE FILLED WITH AUTOLOGOUS BONE PARTICLES WAS IMPLANTED UNDER DIRECT VISION. PEDICLE SCREWS AND ROD WERE FURTHER INSTALLED FOR FIXATION. A TOTAL OF 31 AND 35 CASES IN THE SINGLE INCISION AND DOUBLE INCISION GROUPS, RESPECTIVELY, COMPLETED AT LEAST 12 MONTHS OF SYSTEMIC FOLLOW-UP. ONE PATIENTS WITH COMPLICATION SUPERFICIAL INFECTION AT THE INCISION SITE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465436 APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Other