BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE RELINE SYSTEM

    MDR report key: 11712350 · Received April 22, 2021

    Report

    Report Number
    2031966-2021-00057
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 22, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    NKB
    UDI-DI
    00887517360854
    PMA / PMN Number
    K182974
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AP RADIOGRAPH WAS PROVIDED BUT IT COULD NOT CONFIRM THE ROD DISASSOCIATION. THERE WAS NO REPORTED ACCIDENT AND THE PATIENTS ACTIVITY LEVEL WAS SAID TO BE NORMAL. IT IS UNKNOWN IF FUSION HAS BEEN ACHIEVED. EXAMINATION OF THE DEVICE FOUND NO THREAD DAMAGE BUT POSSIBLE TULIP SPLAY SUGGESTIVELY RELATED TO EXCESSIVE FORCE YET NO ROOT CAUSE WAS DETERMINED. NO ADDITIONAL INVESTIGATION CAN BE COMPLETED AT THIS TIME. LABEL REVIEW: "POTENTIAL ADVERSE EVENTS AND COMPLICATIONS - AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY. INFREQUENT OPERATIVE AND POSTOPERATIVE COMPLICATIONS THAT MAY RESULT IN THE NEED FOR ADDITIONAL SURGERIES. 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." "IF HEALING IS DELAYED, OR DOES NOT OCCUR, THE IMPLANT MAY EVENTUALLY LOOSEN, BEND, OR BREAK. LOADS ON THE DEVICE PRODUCED BY LOAD BEARING AND BY THE PATIENT¿S ACTIVITY LEVEL WILL DICTATE THE LONGEVITY OF THE IMPLANT." "CROSS CONNECTORS ARE DESIGNED SPECIFIC TO THE ROD DIAMETER AND CANNOT BE USED ON THE TAPERED SECTION OF TAPERED RODS. IF USING CROSS CONNECTORS ON TAPERED RODS, ONLY ATTACH THEM ON CONSTANT DIAMETER ROD SECTIONS. CARE SHOULD BE TAKEN TO INSURE THAT ALL COMPONENTS ARE IDEALLY FIXATED PRIOR TO CLOSURE." "ALL LOCK SCREWS SHOULD BE FINAL- TIGHTENED WITH THE COUNTER-TORQUE AND TORQUE T-HANDLE. DO NOT FINAL-TIGHTEN THROUGH COMPRESSION INSTRUMENTS (E.G. C/D RACK AND FIGURE 8 COMPRESSOR) IN THE SET, AS THE ROD MAY NOT BE ABLE TO NORMALIZE TO THE TULIP." "ALL LOCK SCREWS SHOULD BE FINAL-TIGHTENED WITH THE COUNTER-TORQUE AND TORQUE T-HANDLE. DO NOT FINAL-TIGHTEN THROUGH COMPRESSION INSTRUMENTS (E.G. C/D RACK AND FIGURE 8 COMPRESSOR) IN THE SET, AS THE ROD MAY NOT BE ABLE TO NORMALIZE TO THE TULIP." "PATIENT EDUCATION: PREOPERATIVE INSTRUCTIONS TO THE PATIENT ARE ESSENTIAL. THE PATIENT SHOULD BE MADE AWARE OF THE LIMITATIONS OF THE IMPLANT AND POTENTIAL RISKS OF THE SURGERY. 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." "POST-OPERATIVE WARNINGS: DURING THE POSTOPERATIVE PHASE IT IS OF PARTICULAR IMPORTANCE THAT THE PHYSICIAN KEEPS THE PATIENT WELL INFORMED OF ALL PROCEDURES AND TREATMENTS. DAMAGE TO THE WEIGHT-BEARING STRUCTURES CAN GIVE RISE TO LOOSENING OF THE COMPONENTS, DISLOCATION AND MIGRATION, AS WELL AS TO OTHER COMPLICATIONS."

    Description of Event or Problem · 1

    ON A (B)(6) 2021 A REVISION PROCEDURE OCCURRED TO EXTEND THE EXISTING CONSTRUCT TO L2 UTILIZING ROD CONNECTORS. THE PATIENT HEARD A NOISE COMING FROM THEIR BACK ON A UNKNOWN DATE AND IT WAS DISCOVERED IN A SUBSEQUENT FOLLOW UP AT THAT THE RIGHT SIDE ROD HAS DISASSOCIATED. A REVISION OCCURRED ON (B)(6) 2021 TO ADJUST THE SLIPPED ROD. THE SURGICAL WOUND WAS CLOSED, THAT DAY SUBSEQUENTLY IT WAS DISCOVERED THE LEFT SIDE ROD HAD SLIPPED AS WELL. IT WAS REPORTED THAT THE CROSS CONNECTOR WAS AT FAULT FOR THE SLIPPAGE. NO REVISION HAS OCCURRED OR WAS PLANNED AT THE TIME OF REPORTING FOR THE SECOND SLIPPED ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608336 NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INCORPORATED 11104055 AS9182 00887517360854

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention