BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE HELIX ACP SYSTEM

    MDR report key: 14569719 · Received June 1, 2022

    Report

    Report Number
    2031966-2022-00107
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    May 2, 2022
    Report Date
    June 1, 2022
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN WHICH SCREW MALFUNCTIONED. MODEL NUMBER: 7741115 OR 7739115, LOT NUMBER: M45828 OR DP0721, UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). PMA/510(K) NUMBER: K073275 OR K083341. DEVICE MANUFACTURER DATE: JUL 12, 2021 OR OCT 6, 2021. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE RADIOGRAPHIC IMAGES PROVIDED. NO PRODUCT WAS RETURNED TO NUVASIVE FOR EVALUATION AS THE DEVICE REMAINS IN-SITU. OPERATIVE NOTES WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE TO DETERMINE IF THE SCREWS WERE ADEQUATELY SEATED DURING THE INITIAL PROCEDURE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION PROVIDED. HOWEVER, BASED ON REVIEW OF THE RADIOGRAPHIC IMAGES AND PREVIOUS INVESTIGATIONS FOR SIMILAR ISSUES, POTENTIAL CAUSES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT INCLUDE: OFF CENTERED AND OR EXTREME ANGULATION DURING SCREW PLACEMENT, WHICH CAN ALLOW THE WASHER OF THE SCREW WASHER ASSEMBLY TO CONTACT THE EDGE OF THE PLATE AND DAMAGE AND/OR REMOVE THE WASHER, REDUCING THE DIAMETER AND THUS ALLOWING THE SCREW TO PASS THROUGH THE CANTED COIL LOCK AND PLATE ASSEMBLY. OFF CENTERED AND OR EXTREME ANGULATION DURING SCREW PLACEMENT CAN DAMAGE OR REMOVE THE CANTED COIL LOCK DISALLOWING LOCK CONFIRMATION, WHICH CAN LEAD TO OVER ADVANCEMENT OF THE SCREW ASSEMBLY INTO THE BONE, DAMAGING THE PLATE AND ALLOWING EVENTUAL SCREW PULL THROUGH. PATIENT RELATED FACTORS SUCH AS EXCESSIVE POSTOPERATIVE PHYSICAL ACTIVITY OR A FALL AS WELL AS CONTINUED PATHOLOGY OF ADJACENT SEGMENTS. THERE ARE WARNINGS IN THE DEVICE LABELING THAT THIS TYPE OF EVENT CAN OCCUR: " WARNINGS, CAUTIONS AND PRECAUTIONS: THE IMPLANTATION OF SPINAL SYSTEMS SHOULD BE PERFORMED ONLY BY EXPERIENCED SPINAL SURGEONS WITH SPECIFIC TRAINING IN THE USE OF THIS SPINAL SYSTEM BECAUSE THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF SERIOUS INJURY TO THE PATIENT...ALL COMPONENTS SHOULD BE FINAL TIGHTENED PER THE SPECIFICATIONS IN THE SURGICAL TECHNIQUE. IMPLANTS SHOULD NOT BE TIGHTENED PAST THE LOCKING POINT, AS DAMAGE TO THE IMPLANT MAY OCCUR." "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." IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL THREE (3) LEVEL ANTERIOR CERVICAL FIXATION PROCEDURE. SUBSEQUENTLY, POST-OPERATIVE IMAGING OBTAINED APPROXIMATELY SIX (6) WEEKS LATER IDENTIFIED THE RIGHT SCREW AT C7 HAD PASSED THOUGH THE PLATE, POSTERIOR TO THE LOCKING FEATURE. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC EXCEPT FOR A PERCEIVED "CLICK" AT THE IMPLANT LOCATION DURING CERTAIN MOVEMENTS. NO REVISION PROCEDURE HAS BEEN SCHEDULED AT THIS TIME. NO FURTHER PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730752 NUVASIVE HELIX ACP SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ NUVASIVE, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose HELIX ACP PLATE, PN 7738362| HELIX SCREWS, VARIOUS PNS