BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSE CORRECTION KEY

    MDR report key: 10339169 · Received July 29, 2020

    Report

    Report Number
    1526439-2020-01418
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    May 26, 2020
    Report Date
    July 21, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034466156
    PMA / PMN Number
    K142185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS CONDUCTED: INVESTIGATION FLOW: DAMAGE & FUNCTIONAL/DEVICE INTERACTION. VISUAL INSPECTION: THE VERSE CORRECTION KEY (P/N: 199721000, LOT NUMBER: 243958) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THE BOTTOM THREAD WAS TORN, MAKING THE DEVICE UNABLE TO ASSEMBLE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT WAS PERFORMED WITH THE COMPLAINT DEVICE AND THE RETURNED MATING DEVICE. THE COMPLAINT DEVICE WAS UNABLE TO ASSEMBLE TO THE MATING DEVICE DUE TO THE TORN BOTTOM THREAD. THE CONDITION CAN BE REPLICATED. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: DEVICE HISTORY LOT. THE DHR OF PRODUCT CODE 199721000, LOT 243958, WAS REVIEWED AND NO NON-CONFORMANCE WAS OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON (B)(6) 2019. QTY. 199. THE DHR WAS ELECTRONICALLY REVIEWED. 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 ON AN UNKNOWN DATE THAT DURING A SURGERY ON (B)(6) 2020, WHEN THE SURGEON INSERTING THE CORRECTION KEY AND A UNITIZED SET SCREW IN THE EXTENDED TAP OF AN EXP VERSE CFX SCREW, BOTH INNIES ARE BROKE-THE RING/CHIP BROKE OFF. THE SURGEON THEN UNABLE TO USE CORRECTION KEY AND THE UNITIZE THE SET SCREW AND HAD TO CHANGE THE SCREW AND INNIES. ALL GENERATED FRAGMENTS WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES DELAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN KEY INSERTER/TIGHTENER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) VERSE CORRECTION KEY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806016 VERSE CORRECTION KEY ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB MEDOS INTERNATIONAL SàRL CH 199721001 WM2111 10705034466156

    Patients

    Seq Age Sex Outcome Treatment
    1