BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARK STAR PEDICLE SCREW SYSTEM

    MDR report key: 10290357 · Received July 17, 2020

    Report

    Report Number
    3011796723-2020-00001
    Event Type
    Malfunction
    Date Received
    July 17, 2020
    Date of Event
    July 10, 2020
    Report Date
    July 10, 2020
    Manufacturer
    REPUBLIC SPINE, LLC
    Product Code
    NKB
    PMA / PMN Number
    K181495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS BEING RETURNED TO THE MANUFACTURER FOR EVALUATION BUT COULD NOT BE DELIVERED AND EVALUATION COMPLETED WITHIN THE 5-DAY REPORTING PERIOD. THEREFORE, A SUPPLEMENT WILL BE FILED, AS NEEDED, TO PROVIDE THE RESULTS OF THE EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED. THE INSPECTION RECORDS SHOW THAT THE DEVICE LOT WAS INSPECTED ACCORDING TO AN APPROPRIATE SAMPLING PLAN. EIGHT (8) OF THE (4) DEVICES FAILED DUE TO PARTICULATE DEBRIS. A NON-CONFORMANCE WAS DOCUMENTED AND DIS-POSITIONED ALL (8) DEVICES TO BE SCRAPPED AND FOR ALL REMAINING DEVICES IN THE LOT TO BE INSPECTED (100% INSPECTION). RESULTS OF 100% INSPECTION IS THAT ALL DEVICES MET THE ACCEPTANCE CRITERIA. THEREFORE, IT IS CONCLUDED THAT THE SUBJECT PEDICLE SCREW MEETS ALL SPECIFICATIONS AS DEFINED IN THE INSPECTION PROCEDURE. PARTS INVOLVED WITH THIS COMPLAINT ARE: PART NUMBER / LOT / UDI/ DEVICE DESCRIPTION; 100008-8570 / 19407 / B0751000088570 / 8.5 DIA X 70MM LOW TOP PEDICLE SCREW, 100220-8540 / 24807 / B0751002208540 / 8.5 DIA X 40 MM MIS SCREW. DUE TO TECHNICAL DIFFICULTIES, THIS REPORT IS UNABLE TO BE SENT VIA THE ESG ON TIME. THIS REPORT IS FINALIZED AS OF 7/16/2020, BUT WILL BE SENT TO THE FDA VIA ESG AS SOON AS POSSIBLE.

    Description of Event or Problem · 1

    PEDICLE SCREWS AND RODS PLACED T10 - ILIUM BILATERALLY IN THE SPINE. TULIP DISSOCIATED FROM SCREW LOCATED IN THE RIGHT ILIUM (SCREW REMAINS IN THE BONE). SCREW IN S1 PULLED OUT OF BONE. HISTORY LEADING TO EVENT IS AS FOLLOWS: (B)(6) 2020: DATE OF INITIAL SURGERY. PEDICLE SCREWS AND RODS PLACED BILATERALLY FROM T10 TO ILIUM. INTRA-OPERATIVELY, SCREWS WERE INSERTED AND REMOVED FROM L5 (RIGHT SIDE) AND S1 (RIGHT SIDE) DUE TO POOR BONE QUALITY. ADDITIONALLY, SURGEON NOTED TULIP HEAD SPLAYED AT L5 (LEFT SIDE) DURING INSERTION SO L5 SCREW WAS REMOVED AND REPLACED INTRA-OPERATIVELY. UPON CONCLUSION OF SURGERY, ALL SCREWS WERE ANCHORED TO BONE AND CONSTRUCT WAS RIGID, TO SURGEON LIKING. (B)(6) 2020: PATIENT WENT TO EMERGENCY ROOM DUE TO LOWER BACK PAIN. X-RAY SHOWED THE SCREW LOCATED IN RIGHT ILIUM HAD DISASSEMBLED (TULIP HEAD POPPED OFF) BUT RADIOLOGIST READ THE X-RAY INCORRECTLY, DID NOT NOTE AN ISSUE AND SENT THE PATIENT HOME. PATIENT LEFT EMERGENCY ROOM WITHOUT INTERVENTION. (B)(6) 2020: PATIENT CONTACTED OPERATING SURGEON. SURGEON INSTRUCTED THE PATIENT TO GO TO THE EMERGENCY ROOM. REVISION SURGERY SCHEDULED FOR (B)(6) 2020. SURGEON NOTIFIED REPUBLIC SPINE SALES REPRESENTATIVE OF THE EVENT. ACCORDING TO SURGEON, WHEN PATIENT CONTACTED HIM IN JULY, SHE DID NOT MENTION A POTENTIAL CONTRIBUTING EVENT (E.G., FALL, SLIP, ETC.). (B)(6) 2020: REVISION SURGERY COMPLETED SUCCESSFULLY. SINCE THE PATIENT DID NOT RECEIVE MEDICAL/SURGICAL INTERVENTION FOR APPROXIMATELY ONE MONTH AFTER THE RIGHT ILIUM SCREW TULIP HEAD HAD POPPED OFF, THE SURGEON REMOVED AND REPLACED ALL SCREWS AND RODS FOR THE ENTIRE CONSTRUCT (INCLUDING THE RIGHT ILIUM SCREW) AND S1 SCREW THAT BACKED OUT). NEW, LARGER (RESCUE) SCREWS WITH DOUBLE LEAD THREAD WERE UTILIZED FOR THE REVISION SURGERY. THE SURGEON REPLACED ALL SCREWS WITH A COMPETITOR PRODUCT AS A PRECAUTION, DUE TO THE PATIENT BEING MOBILE WITH AN INCOMPLETE IMPLANT CONSTRUCT FOR APPROXIMATELY ONE MONTH AND BECAUSE ANOTHER MANUFACTURER'S SCREW SYSTEM WAS USED AND MIXING SCREWS FROM TWO DIFFERENT SYSTEMS IS NOT RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751681 DARK STAR PEDICLE SCREW SYSTEM THORACOLUMBAR PEDICLE SCREW SYSTEM NKB REPUBLIC SPINE, LLC 100008-8570 19407

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention