BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 7 X 45MM

    MDR report key: 12391820 · Received August 31, 2021

    Report

    Report Number
    1526439-2021-01799
    Event Type
    Injury
    Date Received
    August 31, 2021
    Report Date
    August 2, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNI
    UDI-DI
    10705034282671
    PMA / PMN Number
    K160879
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: MIS TI CFX FEN POLY 7X45 (PART# 186727745, LOT# 210493, QTY# (B)(4)) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THE SCREW SHANK OF THE DEVICE GOT BROKEN AT ITS PROXIMAL END AND THE BROKEN FRAGMENT WAS NOT RETURNED AT CQ. THERE WERE FEW SCRATCHES AND DISCOLORATION OBSERVED ON THE DEVICE WHICH MIGHT HAVE CAUSED DURING EXPLANATION PROCEDURE. ADDITIONALLY, UPON INSPECTING ALL THE IMAGES PROVIDED UNDER NOTES & ATTACHMENTS SECTION, THE MIS TI CFX FEN POLY 7X45 SCREW WAS OBSERVED TO BE BROKEN AND EMBEDDED IN THE BODY THUS, THE REPORTED COMPLAINT IS BEING CONFIRMED. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION OF THE RECEIVED DEVICE WAS NOT PERFORMED AT CQ DUE TO POST MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: THE RELEVANT DOCUMENT(S) WAS REVIEWED: NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. INVESTIGATION CONCLUSION: THE COMPLAINT IS BEING CONFIRMED FOR MIS TI CFX FEN POLY 7X45 (PART# 186727745, LOT# 210493, QTY# (B)(4)) AS THE SCREW SHANK OF THE DEVICE GOT BROKEN AT ITS PROXIMAL END. WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED PROBLEM, IT IS POSSIBLE THAT THE DEVICE MIGHT HAVE ENCOUNTERED UNINTENDED FORCES. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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 DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: THE DEVICE HISTORY REVIEW OF PRODUCT CODE: 186727745, LOT : 210493 WAS ELECTRONICALLY REVIEWED AND NO NON-CONFORMANCES WERE OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: (B)(6) 2018 QTY: (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 · 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. H10 ADDITIONAL NARRATIVE: H6 - CODES UPDATED TO IMDRF CODES. PHOTO INVESTIGATION - THE DEVICE WAS NOT RETURNED. A PHOTO-INVESTIGATION WAS PERFORMED ON THE IMAGES "T.H..JPG, POST IMPLANT X-RAY 1.PNG, POST IMPLANT X-RAY 2.PNG " LOCATED IN PC UNDER NOTES & ATTACHMENTS SECTION. UPON INSPECTING ALL THE IMAGES PROVIDED UNDER NOTES & ATTACHMENTS SECTION, THE MIS TI CFX FEN POLY 7X45 SCREW WAS OBSERVED TO BE BROKEN AND EMBEDDED IN THE BODY. THE ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. CONCLUSION: THE COMPLAINT CONDITION CAN BE CONFIRMED DURING PHOTO/VIDEO INVESTIGATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. NO MANUFACTURING ISSUES WERE NOTED DURING INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. DEVICE HISTORY REVIEW - THE DEVICE HISTORY REVIEW OF WAS ELECTRONICALLY REVIEWED AND NO NON-CONFORMANCES WERE OBSERVED DURING THE MANUFACTURING PROCESS. 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

    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. 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 SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, AFTER A DORSAL EXTENSION WITH FUSION L4/5 THE PATIENT COMPLAINT ABOUT PERSISTENT LUMBAR PAIN. A CT SCAN-MORPHOLOGICAL SHOWED SCREW LOOSENING BILATERALLY. DURING THE CORRECTIVE PROCEDURE, THE REMOVAL OF THE SCREW S1 ON THE RIGHT, WAS ONLY PARTIALLY REMOVED BECAUSE THE SCREW BROKE DISTALLY IN THE AREA OF THE PERFORATION. A NEW SCREW WAS IMPLANTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 7 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295502 VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 7 X 45MM ORTHOSIS, SPINAL PEDICLE FIXATION MNI MEDOS INTERNATIONAL SàRL CH 186727745 210493 10705034282671

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention UNKNOWN LOCKING/SET SCREWS.| UNKNOWN RODS.| UNKNOWN LOCKING/SET SCREWS| UNKNOWN RODS