BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: VIPER 2

    MDR report key: 15421914 · Received September 14, 2022

    Report

    Report Number
    1526439-2022-01590
    Event Type
    Injury
    Date Received
    September 14, 2022
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    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. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: VIPER 2/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: TINELLI, M. ET AL. (2011), PEDICLE SREW [SIC] PLACEMENT ACCURACY USING A PERCUTANEOUS MINIMAL INVASIVE SYSTEM AT TRAUMA PATIENTS, EUROPEAN SPINE JOURNAL, VOL. 20, PAGE 2045 (B)(6). MINIMAL INVASIVE SPINE SURGERY IN TRAUMA PATIENTS IS CHALLENGING. A SHORT OPERATION TIME AND A PERFECT POSITIONING OF PEDICLE SCREWS IS DEMANDED. IN THIS STUDY WE SHOW FOR THE FIRST TIME, THAT THE NEW VIPER®2 MINIMALLY INVASIVE PEDICLE SCREW SYSTEM ALLOWS BOTH. BETWEEN MAY 2009 AND MARCH 2011, 121 PATIENTS (131 FRACTURES) WITH FRACTURES BETWEEN TH 3 AND L 5 WERE TREATED WITH THE VIPER®2 MINIMALLY INVASIVE PEDICLE SCREW SYSTEM. THERE WERE 52 FEMALES AND 69 MEN, THE MEAN AGE AT OPERATION TIME WAS 56.7 YEARS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD REMISSION AFTER SURGERY. 15 SCREWS IN SUBOPTIMAL POSITION, 8 WITH MEDIAL AND 7 LATERAL DEVIATION. BECAUSE OF NO NEUROLOGIC DEBILITY, NO REVISION WAS PERFORMED BECAUSE OF THE SCREW´S POSITION. IN ONE PATIENT, SEPTIC REVISION WITHOUT REMOVAL OF THE SCREWS WAS PERFORMED. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT INVOLVES ONE UNK - CONSTRUCTS: VIPER 2. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2643420 UNK - CONSTRUCTS: VIPER 2 APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention