BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5 EXP VERSE SCR 6.0X45

    MDR report key: 9497395 · Received December 19, 2019

    Report

    Report Number
    1526439-2019-52731
    Event Type
    Injury
    Date Received
    December 19, 2019
    Report Date
    November 27, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    PMA / PMN Number
    K142185
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. H10 ADDITIONAL NARRATIVE: D10: DEVICE RECEIVED. H3, H6: INVESTIGATION SUMMARY BACKGROUND: IT WAS REPORTED THAT ON NOVEMBER 27, 2019 A REVISION OF A POSTERIOR DECOMPRESSION AND FUSION (L4/5) WITH VERSE WAS PERFORMED DUE A LOSE SCREW AND PAIN. THE L4 SCREW ON THE LEFT HAD COME LOSE AND THE L5 LOCKING CAP ON THE RIGHT HAD COMPLETELY DETACHED FROM THE SCREW HEAD. THERE WAS A LOT OF METALLOSIS ON THE RIGHT SIDE. THE PATIENT WAS UPSIZED AND REVISED WITH VERSE ADVANCED EXTENDING UP A LEVEL TO L3. THIS COMPLAINT INVOLVES THREE (3) DEVICES. INVESTIGATION FLOW: FUNCTIONAL/ DAMAGE. VISUAL INSPECTION: 5.5 EXP VERSE SCR 6.0X45 (PART# 199721645S, LOT# AVGDVG, QTY: 4) WAS RECEIVED AT US CQ. BUT THE ALLEGATION WAS AGAINST ONLY ONE DEVICE. UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THE THREE EXTRA SCREWS RECEIVED AT CQ WERE INTACT WITH NORMAL WEAR. ONE OF THE DEVICES GOT FEW SCRATCHES AND A NICKED SPOT ON THE SCREW HEAD AND THE THREADS OF THE SCREW SHANK WERE SLIGHTLY WORN AND DISCOLORED. THE MINOR INNER THREADED DIAMETER OF THE SCREW HEAD WAS MEASURED AND IS WITHIN SPECIFICATIONS. FUNCTIONAL TESTING: FUNCTIONAL INSPECTION OF THE RECEIVED DEVICES WAS PERFORMED AT CQ BY SCREWING IN ALL THE SET SCREWS INTO ALL FOUR VERSE SCREWS SEPARATELY. NO SCREW WAS FOUND TO BE LOOSE. THUS, THE REPORTED COMPLAINT CANNOT BE CONFIRMED. INVESTIGATION CONCLUSION: A VISUAL INSPECTION, DOCUMENT/ SPECIFICATION REVIEW, FUNCTIONAL TESTING, AND DIMENSIONAL INSPECTION WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT CANNOT BE CONFIRMED AS NO SET SCREW WAS OBSERVED TO BE LOOSE WITH VERSE SCREWS, BUT IT IS CONFIRMED THAT THE SCREW HEAD GOT FEW SCRATCHES AND A NICKED SPOT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WHY THE CUSTOMER EXPERIENCED THE REPORTED PROBLEM. NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED, AND NO NEW MALFUNCTIONS WERE IDENTIFIED EITHER. BASED UPON THESE RESULTS, 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. H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT THE DHR OF PRODUCT CODE 199721645S LOT AVGDVG, WAS ELECTRONICALLY REVIEWED AND NO NON-CONFORMANCES WERE OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON JUNE 9TH, 2016. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. ADDITIONAL NUMBER K111136. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (B)(4). 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 THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 A REVISION OF A POSTERIOR DECOMPRESSION AND FUSION (L4/5) WITH VERSE WAS PERFORMED DUE A LOSE SCREW AND PAIN. THE L4 SCREW ON THE LEFT HAD COME LOSE AND THE L5 LOCKING CAP ON THE RIGHT HAD COMPLETELY DETACHED FROM THE SCREW HEAD. THERE WAS A LOT OF METALLOSIS ON THE RIGHT SIDE. THE PATIENT WAS UPSIZED AND REVISED WITH VERSE ADVANCED EXTENDING UP A LEVEL TO L3. THIS REPORT IS FOR ONE 5.5 EXP VERSE SCREW 6.0 X 45. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292517 5.5 EXP VERSE SCR 6.0X45 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDOS INTERNATIONAL SàRL CH AVGDVG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention