BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE VUEPOINT II OCT SYSTEM

    MDR report key: 11615206 · Received April 5, 2021

    Report

    Report Number
    2031966-2021-00048
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    March 12, 2021
    Report Date
    April 5, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    NKG
    UDI-DI
    00887517402370
    PMA / PMN Number
    K180198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION AND NO RADIOGRAPHS PROVIDED TO CONFIRM THE COMPLAINT. IT IS UNKNOWN IS PATIENT FOLLOWED POST-OPERATIVE RESTRICTIONS. PATIENT'S BONE QUALITY IS CONSIDERED POOR. REVIEW OF THE REPORTED EVENT AND COMMUNICATIONS WITH REP IDENTIFIED THE SURGEON ATTRIBUTED THE FAILURE TO THE PATIENT POOR BONE QUALITY IDENTIFIED DURING REVISION PROCEDURE. NO ADDITIONAL INVESTIGATION REQUIRED. LABELING REVIEW: "POTENTIAL ADVERSE EVENTS AND COMPLICATIONS: AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY. POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S), LOSS OF FIXATION." "CONTRAINDICATIONS: CONTRAINDICATIONS INCLUDE, BUT ARE NOT LIMITED TO: 4. PATIENTS WHO ARE UNWILLING TO RESTRICT ACTIVITIES OR FOLLOW MEDICAL ADVICE. 5. PATIENTS WITH INADEQUATE BONE STOCK OR QUALITY. 6. PATIENTS WITH PHYSICAL OR MEDICAL CONDITIONS THAT WOULD PROHIBIT BENEFICIAL SURGICAL OUTCOME." "PATIENT EDUCATION: THE PATIENT SHOULD BE INSTRUCTED TO LIMIT POSTOPERATIVE ACTIVITY, AS THIS WILL REDUCE THE RISK OF BENT, BROKEN OR LOOSE IMPLANT COMPONENTS. THE PATIENT MUST BE MADE AWARE THAT IMPLANT COMPONENTS MAY BEND, BREAK OR LOOSEN EVEN THOUGH RESTRICTIONS IN ACTIVITY ARE FOLLOWED." "PRE-OPERATIVE WARNINGS: 1. ONLY PATIENTS THAT MEET THE CRITERIA DESCRIBED IN THE INDICATIONS SHOULD BE SELECTED. 2. PATIENT CONDITION AND/OR PREDISPOSITIONS SUCH AS THOSE ADDRESSED IN THE AFOREMENTIONED CONTRAINDICATIONS SHOULD BE AVOIDED."

    Description of Event or Problem · 0

    CORRECTED INFORMATION LISTED IN H10.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. NO RADIOGRAPHS PROVIDED TO CONFIRM THE COMPLAINT. IT IS UNKNOWN IS PATIENT FOLLOWED POST-OPERATIVE RESTRICTIONS. PATIENT'S BONE QUALITY IS UNKNOWN. DUE TO LACK OF INFORMATION THE ROOT CAUSE CANNOT BE DETERMINED AND NO ADDITIONAL INVESTIGATION CAN BE COMPLETED. LABELING REVIEW: "POTENTIAL ADVERSE EVENTS AND COMPLICATIONS: AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY. POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S), LOSS OF FIXATION." "WARNINGS, CAUTIONS AND PRECAUTIONS: CARE SHOULD BE TAKEN TO INSURE THAT ALL COMPONENTS ARE IDEALLY FIXATED PRIOR TO CLOSURE." "PATIENT EDUCATION: THE PATIENT SHOULD BE INSTRUCTED TO LIMIT POSTOPERATIVE ACTIVITY, AS THIS WILL REDUCE THE RISK OF BENT, BROKEN OR LOOSE IMPLANT COMPONENTS. THE PATIENT MUST BE MADE AWARE THAT IMPLANT COMPONENTS MAY BEND, BREAK OR LOOSEN EVEN THOUGH RESTRICTIONS IN ACTIVITY ARE FOLLOWED." "PRE-OPERATIVE WARNINGS: CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT."

    Description of Event or Problem · 1

    ON (B)(6) 2020 A SPINAL PROCEDURE WAS CONDUCTED AT OCCIPUT-T2. ON (B)(6) 2021 A REVISION SURGERY WAS CONDUCTED DUE TO THE HARDWARE REPORTEDLY PULLING OUT OF THE PATIENT'S SKULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512457 NUVASIVE VUEPOINT II OCT SYSTEM POSTERIOR CERVICAL SCREW SYSTEM NKG NUVASIVE, INCORPORATED 8976408 00887517402370

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR