BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE COROENT PROCEDURE

    MDR report key: 3080789 · Received April 11, 2013

    Report

    Report Number
    2031966-2013-00013
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 12, 2013
    Report Date
    April 11, 2013
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MQP
    PMA / PMN Number
    E543436
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION OF RETURNED DEVICE CONFIRMS THE REPORTED EVENT. THE ROOT CAUSE OF THE MATERIAL FAILURE IS UNK. THE RESULTING FRACTURE LEAD TO THE REMOVAL OF THE TRIAL AND SUBSEQUENT MINOR DURAL TEAR. EVAL OF THE BROKEN INSTRUMENT, NOTED THAT THE MATING THREADS OF THE TRIAL SHOWED EVIDENCE OF CROSS-THREADING ON TRIAL (6726908, LOT TU0119). IT IS UNK WHETHER THE CROSS-THREADING OCCURRED UPON ATTACHMENT DURING THIS CASE OR PRIOR TO THIS CASE. INSPECTION OF THE BROKEN THREADED TIP AND THE BROKEN SHAFT OF THE TRIAL INSERTER (7000039) SUGGESTS THAT EXCESSIVE TORSIONAL LOAD WAS APPLIED TO THE INSERTER. ACTUAL BREAKAGE OCCURRED DURING SLAP-HAMMER REMOVAL. BASED ON THE PHYSICAL EVIDENCE AND REPORTED INFO, THE SHAFT OF THE TRIAL INSERTER CROSS-THREADED THE TRIAL AND EXCESSIVE TORQUE WAS USED TO FORCE ATTACHMENT. FURTHER STRESSED FROM THE SLAP-HAMMER DISTRACTION FORCES CONTRIBUTED TO THE FAILURE OF THE DEVICE. DEVICE FAILURE MAY HAVE BEEN RELATED TO USER HANDLING. REVIEW OF LABELING NOTES: WARNINGS CAUTIONS AND PRECAUTIONS "...POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS DEVICE SYSTEM, WHICH MAY REQUIRE ADD'L SURGERY, INCLUDE: DEVICE COMPONENT FRACTURE, LOSS OF FIXATION, NON-UNION, FRACTURE OF THE VERTEBRA, NEUROLOGICAL INJURY, AND VASCULAR OR VISCERAL INJURY."

    Description of Event or Problem · 1

    DURING PLACEMENT AN INTERVERTEBRAL BODY FUSION DEVICE THE TRIAL INSERTER BROKE. IN ATTEMPT TO REMOVE THE TRIAL FROM THE DISC SPACE INTRA-OPERATIVELY, THE SURGEON USED A REMOVAL HOOK AND CREATED A MINOR DURAL TEAR. THE SURGEON USED PROLENE AND DURASEAL TO REPAIR THE TEAR AS A COMMON SURGICAL TECHNIQUE. PT IS ASYMPTOMATIC AND IS REPORTEDLY DOING FINE. NO INJURY WAS REPORTED TO HAVE OCCURRED. THERE IS NO PLAN FOR ADD'L SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155245 NUVASIVE COROENT PROCEDURE INTERVERTEBRAL BODY FUSION DEVICE MQP NUVASIVE, INC. 7000039 EM3069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention