BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKY 1 LEVEL PLTE 18MM TI

    MDR report key: 13864598 · Received March 23, 2022

    Report

    Report Number
    1526439-2022-00445
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    December 20, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    KWQ
    UDI-DI
    10705034411866
    PMA / PMN Number
    K171439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: REPORTER IS A SYNTHES EMPLOYEE. PRODUCT CODE: 186801018S. LOT: 267274 MANUFACTURE DATE: JANUARY 6, 2020. MANUFACTURING LOCATION: (B)(4). EXPIRATION DATE: JUNE 13, 2047 A SEARCH WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SKY 1 LEVEL PLTE 18MM TI WAS DAMAGED. THE PLATE PRESENTS A SHAPE DEFORMATION AND ON THE CAM LOCKS SHAPE. THE SCREWS THAT CANNOT BE DISASSEMBLED FROM THE PLATE ARE AT ANGLES THAT EXCEED THE RECOMMENDATION OF THE TECHNIQUE GUIDE. THE ANGLE OF THE SCREW MOST LIKELY CAUSED EXCESSIVE FORCE TO BE REQUIRED TO UNLOCK THE CAM RESULTING IN THE OBSERVED DAMAGE AND INABILITY TO UNLOCK THE SCREWS. THE FINDINGS ARE CONSISTENT WITH REPORTED "UNABLE TO DISASSEMBLE" CONDITION. NO OTHER ISSUES WERE FOUND. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO POST MANUFACTURING DAMAGE. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED FOR SKY 1 LEVEL PLTE 18MM TI AS THE OBSERVED CONDITION WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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. *********************************************** DRAWING/SPECIFICATIONS REVIEWED CURRENT AND MANUFACTURED REVISIONS WERE 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 · 0

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE CAM LOG MECHANISM COULDN'T BE OPENED TO REMOVE THE SCREWS. THE SCREWS NEEDED TO BE OPENED TO RE-POSITION THE PLATE. THE SURGEON ENDED UP REMOVING THE PLATE WITH THE SCREWS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRTY MINUTE DELAY. PATIENT STATUS WAS GOOD. UPON MANUFACTURER RECEIPT AND INVESTIGATION OF THE DEVICE, IT WAS DETERMINED THAT THE ANGLE OF THE SCREWS MOST LIKELY CAUSED EXCESSIVE FORCE TO BE REQUIRED TO UNLOCK THE CAM RESULTING IN THE PLATE DEFORMATION AND INABILITY TO UNLOCK THE SCREWS. THIS REPORT IS FOR A SKY 1 LEVEL PLTE 18MM TI. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863835 SKY 1 LEVEL PLTE 18MM TI APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDOS INTERNATIONAL SàRL CH 186801018S 267274 10705034411866

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown UNKNOWN SCREWS