BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - MONO/POLYAXIAL SCREWS: VIPER 2

    MDR report key: 18061519 · Received November 2, 2023

    Report

    Report Number
    1526439-2023-02196
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. H10 ADDITIONAL NARRATIVE: D1, D2, D3, D4, G4-510K: THIS REPORT IS FOR AN UNKNOWN VIPER 2 PEDICLE SCREWS AND RODS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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 · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: JIA, L. ET AL (2018), SUPERIOR FACET JOINT VIOLATIONS DURING SINGLE LEVEL MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION: A PRELIMINARY RETROSPECTIVE CLINICAL STUDY, BIOMED RESEARCH INTERNATIONAL, VOL. 2018 (ARTICLE ID 6152769), PAGES 1-7 (CHINA). THE AIM OF THIS RETROSPECTIVE STUDY IS SUPPORT THAT A COMPREHENSIVE UNDERSTANDING OF THE FACTORS INVOLVED IN DIFFERENT LEVELS OF FACET JOINT VIOLATION (FV) AND HOW THEY ARE CORRELATED WITH CLINICAL OUTCOMES IS A CRITICAL COMPONENT IN AVOIDING REVISION SURGERY FOR SYMPTOMATIC ASD. BETWEEN JULY 2013 AND DECEMBER 2015, A TOTAL OF 99 PATIENTS (51 MALE AND 48 FEMALE, AVERAGE AGE: 54.57 ± 12.44 YEARS OLD) WHO UNDERWENT ONE-LEVEL MIS-TLIF WERE INCLUDED IN THE STUDY. SURGERY WAS PERFORMED USING PIPELINE WORKING CHANNEL (JOHNSON & JOHNSON COMPANY, NY, USA) OR DIRECTLY USING SPOTLIGHT WORKING CHANNEL (JOHNSON & JOHNSON COMPANY, NY, USA), AND PLACEMENT OF PERCUTANEOUS PEDICLE SCREWS WAS PERFORMED USING VIPER 2 SYSTEM (JOHNSON & JOHNSON COMPANY, NY, USA), AND PERCUTANEOUS ROD WAS ALSO PLACED USING THE INSTRUMENTS AND PRELOCKED. AMONG THE PATIENTS, 53 CASES WERE FOLLOWED UP AFTER ONE YEAR, 31 CASES IN NONINJURY (GROUP A) AND 22 PATIENTS IN FV INJURY (GROUP B). THE FOLLOW-UP PERIOD WAS 18.26 ± 3.78 AND 18.59 ± 4.24 IN GROUP A AND B, RESPECTIVELY. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A TOTAL OF 46 SCREWS IN 39 PATIENTS HAD FACET JOINT VIOLATION IN MIS-TLIF: 32 CASES HAD GRADE 2 UNILATERAL FACET JOINT VIOLATION (SCREW HEAD CONTACTED OR INVADED FACET JOINT) AND 7 CASES HAD GRADE 3 BILATERAL FACET JOINT VIOLATION (SCREW HEAD CONTACTED OR INVADED FACET JOINT). ADJACENT SEGMENT AVERAGE DISC HEIGHT DECREASED AT 1-YEAR FOLLOW-UP WHEN COMPARED TO 3 DAYS¿ POSTOPERATIVE VALUES IN BOTH GROUPS. HOWEVER, ADJACENT SUPERIOR INTERVERTEBRAL DISC COBB ANGLE INCREASED AT 1-YEAR FOLLOW-UP WHEN COMPARED TO 3 DAYS¿ POSTOPERATIVE VALUES IN BOTH GROUPS. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE MONO/POLYAXIAL SCREWS: VIPER 2 .THIS REPORT CAPTURES THE REPORTED EVENTS A TOTAL OF 46 SCREWS IN 39 PATIENTS HAD FACET JOINT VIOLATION IN MIS-TLIF: 32 CASES HAD GRADE 2 UNILATERAL FACET JOINT VIOLATION (SCREW HEAD CONTACTED OR INVADED FACET JOINT) AND 7 CASES HAD GRADE 3 BILATERAL FACET JOINT VIOLATION (SCREW HEAD CONTACTED OR INVADED FACET JOINT). - ADJACENT SEGMENT AVERAGE DISC HEIGHT DECREASED AT 1-YEAR FOLLOW-UP WHEN COMPARED TO 3 DAYS¿ POSTOPERATIVE VALUES IN BOTH GROUPS. HOWEVER, ADJACENT SUPERIOR INTERVERTEBRAL DISC COBB ANGLE INCREASED AT 1-YEAR FOLLOW-UP WHEN COMPARED TO 3 DAYS¿ POSTOPERATIVE VALUES IN BOTH GROUPS. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334285 UNK - MONO/POLYAXIAL SCREWS: VIPER 2 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention