BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MNTR OC PLATE MEDIUM

    MDR report key: 7234147 · Received February 1, 2018

    Report

    Report Number
    1526439-2018-50097
    Event Type
    Malfunction
    Date Received
    February 1, 2018
    Date of Event
    January 19, 2018
    Report Date
    January 19, 2018
    Manufacturer
    DEPUY SPINE INC
    Product Code
    NKG
    UDI-DI
    10705034158884
    PMA / PMN Number
    K042508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). VISUAL EXAMINATION OF THE MNTR OC PLATE MEDIUM REVEALED THAT ONE OF THE SCREW TABS THREADS WERE TORN AND SHREDDED OFF FROM THE PLATE BODY. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING. A DEFINITIVE ROOT CAUSE FOR THE THREADS BEING TORN ON THE MNTR OC PLATE MEDIUM CANNOT BE DETERMINED. A POTENTIAL ROOT CAUSE COULD BE DUE TO INADVERTENTLY CROSS-THREADING THE SET SCREW WITH THE SCREW ON THE PLATE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS WERE FOUND, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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

    OHE OF THE MOUNTAINEER OC INNER SCREWS WOULDN¿T SEAT PROPERLY AT THE END OF THE CASE, DURING FINAL TIGHTENING. DR. (B)(6) HAD TO REMOVE THE PLATE, WASHER, AND OCCIPITAL SCREWS. HE THEN REPLACED ALL THE ITEMS WITH NEW IMPLANTS. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION: ADDED TIME (20 MINUTES) TO SURGERY, NO PATIENT INJURY. ACTION TAKEN FOR PROCEDURE: ASKED SURGEON TO REPLACE THE FIRST STRIPPED OC SETSCREW. HE ATTEMPTED THIS THREE TIMES BEFORE DECIDING TO REMOVE AND REPLACE THE OCCIPITAL IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78071 MNTR OC PLATE MEDIUM ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION NKG DEPUY SPINE INC WA3616 10705034158884

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR