BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: SKYLINE

    MDR report key: 12705150 · Received October 27, 2021

    Report

    Report Number
    1526439-2021-02265
    Event Type
    Injury
    Date Received
    October 27, 2021
    Report Date
    September 30, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS FOR AN UNK - PLATES: SKYLINE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. REPORTER IS A J&J REPRESENTATIVE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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.

    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. UPDATED EVENT DESCRIPTION UPDATED MANUFACTURER EMAIL UPDATED MANUFACTURER CONTACT INFORMATION 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: THE CURRENT REPORT IS A RETROSPECTIVE ANALYSIS OF 133 PATIENTS (57 FEMALES AND 76 MALES) WHO UNDERWENT INSTRUMENTATION WITH CERVIOS BETWEEN JANUARY 02, 2006, AND NOVEMBER 22, 2020. IN 1 CASE IT WAS COMBINED WITH SKYLINE. 15 CASES COMBINED WITH ANTERIOR NON-DEPUY DEVICES WERE EXCLUDED, LEAVING 118 CASES FOR ANALYSIS. MEAN AGE OF THE PATIENTS WAS 51 YEARS. REGISTERED INTRA-OPERATIVE COMPLICATIONS: 1 DURAL TEAR. 3 ROOT INJURY. 2 OTHER. REINTERVENTIONS DURING INDEX STAY: 1 ADJUSTMENT IMPLANT. REGISTERED POST-OP COMPLICATIONS WITHIN 1 YEAR: 15 DYSPHAGIA. 10 RECURRENT NERVE INJURY. READMISSIONS: 1 REDECOMPRESSION. 1 SUBSEQUENT REOPERATION AT A NEW INDEX LEVEL. GLOBAL ASSESSMENT OF NECK PAIN (GA) FAILURE % : FU 1 YRS. 49%, FU 2 YRS. 48% FU 5 YRS. 47%. GLOBAL ASSESSMENT OF ARM PAIN (GA) FAILURE % : FU 1 YRS. 40%, FU 2 YRS. 40% FU 5 YRS. 47%. THIS IS FOR DEPUY SPINE SKYLINE. THIS REPORT IS FOR ONE (1) DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWEDEN AS FOLLOWS: THE CURRENT REPORT IS A RETROSPECTIVE ANALYSIS OF 133 PATIENTS (57 FEMALES AND 76 MALES) WHO UNDERWENT INSTRUMENTATION WITH CERVIOS BETWEEN JANUARY 02, 2006, AND NOVEMBER 22, 2020. IN 1 CASE IT WAS COMBINED WITH SKYLINE. 15 CASES COMBINED WITH ANTERIOR NON-DEPUY DEVICES WERE EXCLUDED, LEAVING 118 CASES FOR ANALYSIS. MEAN AGE OF THE PATIENTS WAS 51 YEARS. REGISTERED INTRA-OPERATIVE COMPLICATIONS: 1 DURAL TEAR. 3 ROOT INJURY. 2 OTHER. REINTERVENTIONS DURING INDEX STAY: 1 ADJUSTMENT IMPLANT. REGISTERED POST-OP COMPLICATIONS WITHIN 1 YEAR: 15 DYSPHAGIA. 10 RECURRENT NERVE INJURY. READMISSIONS: 1 REDECOMPRESSION. 1 SUBSEQUENT REOPERATION AT A NEW INDEX LEVEL. GLOBAL ASSESSMENT OF NECK PAIN (GA) FAILURE % : FU 1 YRS. 49%, FU 2 YRS. 48% FU 5 YRS. 47%. GLOBAL ASSESSMENT OF ARM PAIN (GA) FAILURE % : FU 1 YRS. 40%, FU 2 YRS. 40% FU 5 YRS. 47%. THIS IS FOR DEPUY SPINE SKYLINE. THIS REPORT IS FOR ONE (1)UNK - PLATES: SKYLINE. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 0

    UPDATED: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA) "DEPUY SPINAL IMPLANTS SUBREPORT 15 ¿ CERVIOS" FOR A TOTAL OF 151 PATIENTS (136 WERE FEMALES) WHO UNDERWENT INSTRUMENTATION WITH CERVIOS BETWEEN (B)(6) 2006 AND (B)(6), 2022. IN 2 CASES IT WAS COMBINED WITH SKYLINE. 15 CASES COMBINED WITH ANTERIOR NON-DEPUY DEVICES WERE EXCLUDED, LEAVING 118 CASES FOR ANALYSIS. MEAN AGE OF THE PATIENTS WAS 51 YEARS. COMPLICATIONS REPORTED IN SWEDISH SPINE REGISTRY (SWESPINE) WERE: REGISTERED INTRA-OPERATIVE COMPLICATIONS (N=5): - 1 DURAL TEAR - 1 HEMATOMA - 1 ROOT INJURY - 2 OTHER REGISTERED POST-OP COMPLICATIONS WITHIN 1 YEAR (N=27): - 16 DYSPHAGIA - 11 RECURRENT NERVE INJURY REOPERATIONS (N=2): - 1 ADJUSTMENT IMPLANT - 1 REDECOMPRESSION THIS IS FOR DEPUY SPINE SKYLINE. THIS REPORT IS FOR ONE (1)UNK - PLATES: SKYLINE THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602514 UNK - PLATES: SKYLINE APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention