BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 EXP VERSE CAN SCR 7.0X45

    MDR report key: 7137712 · Received December 21, 2017

    Report

    Report Number
    1526439-2017-50108
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    October 26, 2017
    Report Date
    October 26, 2017
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    UDI-DI
    10705034440934
    PMA / PMN Number
    K142185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE THREADS INSIDE THE TULIP HEAD WERE TORN WITH MINOR DAMAGE TO THE DRIVE FEATURE. 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 FOR THE TORN THREADS 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS REPORT IS BEING SUBMITTED AT THE REQUEST OF THE FDA AS IT WAS DETERMINED THAT A FOLLOW UP REPORT IN THE SEQUENCE OF THIS MFR NUMBER WAS MISSING. THIS REPORT IS BEING SUBMITTED TO FILL IN THAT MISSING FOLLOW UP NUMBER. H11: ADDITIONAL NARRATIVE: D4, H4.

    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.

    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
    917756 5.5 EXP VERSE CAN SCR 7.0X45 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE 143270 10705034440934

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown