BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S100

    MDR report key: 6486976 · Received April 12, 2017

    Report

    Report Number
    3007932279-2017-00002
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Date of Event
    March 17, 2017
    Report Date
    April 6, 2017
    Manufacturer
    RENOVIS SURGICAL TECHNOLOGIES, INC.
    Product Code
    KWP
    UDI-DI
    00841523106974
    PMA / PMN Number
    K101682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION WAS RECEIVED IN WRITING. THE COMPLAINT WAS CONCERNING THE TI ALLOY DIA 5.5MM ROD, L480 MM ROD FOR THE S100 PEDICLE SCREW SYSTEM, RENOVIS PART# 1101-053-480, LOT# 1476-11. PER THE RECEIVED DOCUMENTATION THE SURGERY TOOK PLACE (B)(6) 2014, ONE ROD WAS FRACTURED BY (B)(6) 2015, AND BOTH RODS WERE FRACTURED BY (B)(6) 2015. DR. (B)(6) PERFORMED REVISION SURGERY ON (B)(6) 2015. PER A PHONE CONVERSATION WITH THE SALES REP (AC) ON (B)(6) 2017, THE PEDICLE SCREWS UTILIZED IN THE ORIGINAL PROCEDURE WERE NOT MANUFACTURED BY RENOVIS SURGICAL TECHNOLOGIES. THE RENOVIS S100 IFU# 4101-001 STATES THE FOLLOWING IN THE GENERAL CONDITIONS OF USE SECTION: THE S 100 PEDICLE SCREW SYSTEM SHOULD NOT BE USED IN CONJUNCTION WITH COMPONENTS FROM A DIFFERENT SOURCE, A DIFFERENT MANUFACTURER, OR MADE OF A DIFFERENT MATERIAL. THE FRACTURED RODS HAVE NOT BEEN RETURNED TO RENOVIS. WITHOUT X-RAY IMAGES AND/OR THE EXPLANTED RODS, THE CAUSE OF THE FAILED RODS CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2017 RENOVIS SURGICAL TECHNOLOGIES CUSTOMER SERVICE (KJ) WAS NOTIFIED OF A COMPLAINT THAT 2 TITANIUM RODS USED IN A SPINAL FUSION SURGERY HAD FRACTURED AND REVISION SURGERY HAD BEEN PERFORMED TO REPLACE THE FRACTURED RODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268618 S100 STRAIGHT ROD 5.5MM DIAMETER 480MM LENGTH TI6AL4V KWP RENOVIS SURGICAL TECHNOLOGIES, INC. S100 1476-11 00841523106974

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention