BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 EXP VERSE DI SET SCR

    MDR report key: 7138122 · Received December 21, 2017

    Report

    Report Number
    1526439-2017-50114
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    October 26, 2017
    Report Date
    November 28, 2017
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    UDI-DI
    10705034466125
    PMA / PMN Number
    K142185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> (B)(4). DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS. 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

    PRODUCT COMPLAINT # (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED SIGNIFICANT DAMAGE TO THE THREADS OF BOTH INNER AND OUTER SCREWS. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A TREND ANALYSIS WAS CONDUCTED. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS DAMAGE MAY HAVE OCCURRED DUE TO CROSS-THREADING A SET SCREW UPON INSERTION. 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 WERE FOUND, 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.

    Description of Event or Problem · 1

    ACCOUNT NAME: (B)(6). ON (B)(6) 2017, SURGERY FOR ADULT SPINAL DEFORMITY (ASD) WAS PERFORMED USING THE EXPEDIUM VERSE SYSTEM. THE FIXED AREA WAS L1 - S1. DURING THE SURGERY, THE FOLLOWING IMPLANTS WERE BROKEN AT THE TIME OF FINAL TIGHTENING, COMPRESSION, DISTRACTION. - 5.5 EXP VERSE CAN SCR 7.0X45 (PART#: 199725745S, LOT#: 143270): 3 PIECES. - 5.5 EXP VERSE DI SET SCR (PART#: 199721000S, LOT#: 142642): 6 PIECES. - 5.5 EXP VERSE UNITIZED SET SCR (PART#:199721001S, LOT#: TM1222): 10 PIECES. THREE SCREWS SEEMED TO BE CROSS THREADED IN THE HEAD, THUS SET SCREW COULD NOT BE INSERTED. THE SURGEON REMOVED THE SCREWS AND INSERTED NEW ONES. IT APPEARED THAT SOME BROKEN PARTS DUE TO CROSS-THREAD WERE POSSIBLY LEFT BETWEEN L3 AND S1. THE SURGERY WAS COMPLETED WITH A 120-MINUTE DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918448 5.5 EXP VERSE DI SET SCR ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE 142642 10705034466125

    Patients

    Seq Age Sex Outcome Treatment
    1