BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYLINE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 42MM

    MDR report key: 20943646 · Received December 16, 2024

    Report

    Report Number
    1526439-2024-02997
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 1, 2024
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    KWQ
    PMA / PMN Number
    K171439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. H11 ADDITIONAL NARRATIVE: PHOTO INVESTIGATION: THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT THERE ARE PLATES WITHOUT BENDING WHEN COMPARED TO OTHERS THAT DO EXHIBIT BENDING. HOWEVER, THESE PLATES CORRESPOND TO PRODUCT NUMBER 186803042, WHICH ARE IDENTIFIED AS SHORT LEVEL PLATES. ACCORDING TO THE SKILINE CATALOG 51662-230616 07/23, ¿SHORTER LEVEL PLATES HAVE A MEDIAL SLOT ONLY. ADDITIONALLY, IN THE SURGICAL TECHNIQUE GUIDE 1220221-210120 EMEA 02/21 DOES NOT SPECIFY THAT MULTI-LEVEL PLATES LACK BENDING ZONES, IT ONLY STATE THAT SINGLE LEVEL PLATES DO NOT HAVE BENT ZONES AND THEREFORE CANNOT BE BENT. THEREFORE, IT IS REASONABLE TO CONCLUDE THAT THESE PLATES CANNOT BE ASSEMBLED USING THE "PLATE BENDER" INSTRUMENT, AS THEY DO NOT HAVE A DESIGNATED BENDING ZONE. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE SKY 3 LEVEL PLTE 42MM TI WOULD HAVE NOT CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW: THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. 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. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 · 0

    IT WAS REPORTED THAT SOME SKYLINE PLATES CAN NO LONGER BE BENT WITH THE SKYLINE BENDING PLIERS (286860200 PLATE BENDING INSTRUMENT). THE PLIERS DO NOT FIT THE PLATE. INSPECTION OF THE IMPLANTS SHOWS THAT THE IMPLANTS THAT DO NOT FIT INTO THE BENDING PLIERS HAVE A DIFFERENT PLATE DESIGN THAN THE PLATES THAT CAN BE BENT. THESE PLATES HAVE AN ELONGATED SLOT IN THE BENDING ZONE, WHILE THE BENDABLE PLATES HAVE A MORE SQUARE RECESS INTO WHICH THE BENDING PLIERS FIT. THERE WAS NO PATIENT INVOLVEMENT. THE ISSUE WAS NOTED PREOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2328174 SKYLINE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 42MM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SKY PLATE BENDER