BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.2MM TI CLICK'X® PEDICLE SCR PREASSEMBLED 45MM THRD LENGTH

    MDR report key: 7769953 · Received August 9, 2018

    Report

    Report Number
    8030965-2018-55601
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    April 24, 2018
    Report Date
    May 15, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MNH
    UDI-DI
    10705034792385
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. ADDITIONAL DEVICE PRODUCT CODES: MNI, NKB, KWP, KWQ. DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR PART: 498.989, LOT: 8994158: MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 23. MAY 2014: THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 19 PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS CONDUCTED. THE IMPLANT WAS RECEIVED WITH THE REPORTED CONDITION OF ¿VISUAL STRIPPED/WORN/TWISTED/CROSS THREADED: NRM¿ THE FOLLOWING INVESTIGATION FLOW WERE PERFORMED: DEVICE INTERACTION/FUNCTIONAL & DAMAGE: VISUAL (APPEARANCE NOT AS EXPECTED). IT WAS VISUALLY OBSERVED THAT THE LOCKING HEAD PORTION OF THE IMPLANT FELL APART IN ADDITION THERE IS DAMAGE TO THE TOP OF THE SCREW PORTION (MOSTLY LIKELY DONE BY PLIERS TO REMOVE THE SCREW, AS MATERIAL IS BENT AND ROLLED OVER) AND THE TOP PROXIMAL THREADS SHOWINGS SIGNS OF ROLLING. A FUNCTIONAL TEST WAS NOT PERFORMED AS THE SCREW HEAD FALLING PART WAS ABLE TO BE VISUALLY CONFIRMED. THE RECEIVED CONDITION DOES AGREE WITH THE COMPLAINT DESCRIPTION. THE COMPLAINT IS CONFIRMED. DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST MANUFACTURE DAMAGE. A REVIEW OF THE CURRENT DESIGN DRAWING AND THE DRAWING REVISION AT THE TIME OF MANUFACTURE WAS PERFORMED: TOP LEVEL AND NO ISSUES WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE COMPLAINT CONDITION A POSSIBLE CAUSE COULD BE TOO MUCH FORCE WAS APPLIED DURING INSERTION RESULTING IN THE HEAD POPPING OFF AND USE OF PLIERS TO REMOVE THE SCREW. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A LUMBAR ARTHRODESIS PROCEDURE. THE CLICK X PEDICLE SCREW DUSTED THE THREAD IN THE FINAL TIGHTENING. DURING THE PROCEDURE THERE WAS LOSS OF THE THREAD OF 2 PEDICLE SCREWS, MAKING THE SURGICAL PROCEDURE DIFFICULT. IT WAS NECESSARY TO USE PRESSURE TO REMOVE THE SCREW. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO PATIENT OUTCOME REPORTED. DURING MANUFACTURER¿S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE LOCKING HEAD PORTION OF THE IMPLANT FELL APART IN ADDITION THERE IS DAMAGE TO THE TOP OF THE SCREW PORTION (MOSTLY LIKELY DONE BY PLIERS TO REMOVE THE SCREW, AS MATERIAL IS BENT AND ROLLED OVER) AND THE TOP PROXIMAL THREADS SHOWINGS SIGNS OF ROLLING. THIS DEVICE CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2018. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608606 6.2MM TI CLICK'X® PEDICLE SCR PREASSEMBLED 45MM THRD LENGTH ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION MNH OBERDORF SYNTHES PRODUKTIONS GMBH 498.989 8994158 10705034792385

    Patients

    Seq Age Sex Outcome Treatment
    1