BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE-INNER SETSCREW

    MDR report key: 5050418 · Received September 2, 2015

    Report

    Report Number
    1526439-2015-10760
    Event Type
    Injury
    Date Received
    September 2, 2015
    Date of Event
    August 4, 2015
    Report Date
    August 5, 2015
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK033901
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PER AFFILIATE ONLY ONE SET SCREW HAD LOOSENED. HOWEVER, IT IS UNKNOWN WHICH OF THE TWO TYPES OF SET SCREWS [1797-02-000 AND 1867-15-000] HAD LOOSENED POSTOPERATIVELY . AS SUCH ONLY ONE OF THE SET SCREWS FROM EACH PRODUCT CODE [1797-02-000 AND 1867-15-000] WAS CODED: SPINE: IMPLANT FAILURE: LOOSENING. EIGHT SINGLE INNER SET SCREWS [PRODUCT CODE: 1797-02-000, LOT NUMBER: AMBD11], VISUAL INSPECTION OF THE SET SCREWS [PRODUCT CODE: 1797-02-000] WERE RETURNED TO THE COMPLAINTS HANDLING UNIT (CHU) FOR EVALUATION. SHOWED THAT FOUR OUT OF THE EIGHT SET SCREWS HAD A STRIPPED HEXALOBE FEATURE. WITNESS MARKS, WHICH IS A STRAIGHT LINE IMPRESSED ON THE BACK OF THE SET SCREWS, WAS NOTED ON ONLY ONE OF THE SET SCREWS. THE REMAINING SEVEN HAD MARKINGS ON THE BACK; HOWEVER THERE WERE NO IMPRESSIONS, INDICATING THAT THE SET SCREWS WERE FINAL TIGHTENED ONTO THE ROD, PRESENT. NO OTHER ABNORMALITIES WERE NOTED FOR THESE SET SCREWS. THE ROOT CAUSE FOR THE SET SCREW LOOSENING POSTOPERATIVELY CANNOT BE POSITIVELY DETERMINED. PER THE VISUAL INSPECTION IT WAS NOTED THAT ONLY ONE OF THE SET SCREWS [1797-02-000] EXHIBITED WITNESS MARKS, WHICH SUGGESTS THAT THIS SET SCREW WAS FINAL TIGHTENED ONTO THE ROD. THE OTHER SET SCREWS HAD MARKINGS ON THEIR BACK WHICH INDICATES THAT THESE SET SCREWS MADE CONTACT WITH THE ROD, HOWEVER THEY DID NOT HAVE THE IMPRESSION MARKS, WHICH SUGGESTS THAT THESE SET SCREWS WERE NOT FINAL TIGHTENED ONTO THE RODS. WITNESS MARKS WERE NOTED ON THE RETURNED MIS SET SCREWS [1867-15-000] AND THE TWO UNKNOWN SET SCREWS, WHICH SUGGEST THAT THESE SET SCREWS WERE FINAL TIGHTENED ONTO THE RODS. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS REQUIRING IMMEDIATE ACTION HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    EXPEDIUM, PEDICLE SCREW SPINE SYSTEM. THE PATIENT HAD ORIGINAL SURGERY IN 2011, L2-PELVIS POSTERIOR SPINAL FUSION. BOOKED FOR REVISION SURGERY, (B)(6) 2015 FOR EXTENSION OF FUSION, T11-PELVIS, DUE TO INSTABILITY OF FUSION, IMPLANTS APPEAR TO HAVE MOVED. IT WAS NOTED THAT THE SI SET SCREWS AT L2 AND L3 WERE LOOSE AND THE ROD ON THE RIGHT SIDE WAS BROKEN WHEN REMOVED FROM THE PATIENT. THE SCREWS AT L2, 3 AND 4 WERE REMOVED AND REPLACED WITH OTHER EXPEDIUM PEDICLE SCREWS AND THEN THE CONSTRUCT WAS EXTENDED UP TO T11 TO PROVIDE ADEQUATE STABILIZATION AND FUSION. BOTH RODS AND ALL THE SI SET SCREWS WERE REPLACED. PATIENT RECOVERING SATISFACTORILY AT THE TIME OF THIS REPORT. PATIENT DETAILS; ID (B)(6). (B)(6) MALE. (B)(6). X-RAYS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580573 SINGLE-INNER SETSCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other