BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT

    MDR report key: 1930822 · Received December 16, 2010

    Report

    Report Number
    1030489-2010-01596
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    January 5, 2010
    Report Date
    December 7, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    GAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: ANAND, ET AL. MID-TERM TO LONG-TERM CLINICAL AND FUNCTIONAL OUTCOMES OF MINIMALLY INVASIVE CORRECTION AND FUSION FOR ADULTS WITH SCOLIOSIS. NEUROSURG FOCUS. 2010; 28 (3): RHBPM-2, PEDICLE SCREWS. NO THERAPY OR IMPLANT DATES WERE GIVEN. (B)(4): THE EVENT IS BELIEVED TO BE ASSOCIATED WITH THE SURGICAL TECHNIQUE AND/OR INSTRUMENTS USED DURING THE PROCEDURE. NO DEVICE RETURN: THIGH DYSESTHESIAS AFTER DLIF/XLIF ARE ALMOST ALWAYS RELATED TO RETRACTION OR SPACER PLACEMENT - SOMEWHAT COMMON IN THIS PROCEDURE. THERE WAS NO MENTION BY THE AUTHORS OF OTHER POTENTIAL ASSOCIATED SEQUELAE CAUSING SUCH COMPLICATIONS, AND THEREFORE IS NOT BELIEVED TO BE DEVICE-RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALL COMPLICATIONS WERE ASSOCIATED WITH THE LATERAL APPROACH AND NOTHING CONCERNED WITH BONE MORPHOGENETIC PROTEIN (BMP), DIRECT LATERAL INTERBODY FUSION (DLIF) PROCEDURE OR LONGITUDE.

    Description of Event or Problem · 1

    IN A RETROSPECTIVE STUDY, CLINICAL DATA WAS REVIEWED FOR (B)(6) CONSECUTIVE PATIENTS WHO UNDERWENT FUSION OVER THREE OR MORE LEVELS, AND HAD A MINIMUM OF ONE YEAR OF FOLLOW-UP. ALL PATIENTS HAD SEVERE PREDOMINANTLY LOW- TO MIDDLE-BACK PAIN. ALL PATIENTS HAD PARTICIPATED IN EXTENSIVE CONSERVATIVE THERAPIES WITHOUT ADEQUATE RELIEF OF THEIR SYMPTOMS BEFORE BEING CONSIDERED FOR SURGERY. THE MEAN AGE OF THE PATIENTS IN THE STUDY WAS 67.7 YEARS. THE PATIENTS UNDERWENT A SINGLE OR COMBINATION OF SURGICAL INTERBODY DISC RELEASE AND FUSION PROCEDURES: AXIALIF (AXIAL LUMBAR INTERBODY FUSION), DLIF (DIRECT LATERAL INTERBODY FUSION), OR XLIF (EXTREME LATERAL INTERBODY FUSION). THE AMOUNT OF RHBMP-2/ACS USED VARIED WITH SURGICAL TECHNIQUE AND LEVEL TREATED. FROM THE DATA PRESENTED, IT IS NOT POSSIBLE TO DETERMINE THE SURGICAL TECHNIQUE, LEVELS TREATED, OR RHBMP-2 DOSE FOR A SPECIFIC PATIENT. ALL PATIENTS MAINTAINED CORRECTION OF THEIR DEFORMITY AND WERE NOTED TO HAVE SOLID ARTHRODESIS ON PLAIN RADIOGRAPHS AT ONE YEAR FOLLOW-UP. (B)(6) PATIENTS WERE NOTED TO HAVE IMMEDIATE POSTOPERATIVE THIGH DYSESTHESIAS, WHICH RESOLVED WITHIN SIX WEEKS OF SURGERY. ALL PATIENTS SHOWED FUSION ON IMAGING STUDIES WITH NO EVIDENCE OF PSEUDARTHROSIS. NO OTHER DETAILS WERE MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET GAD MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention