BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SCREWS

    MDR report key: 17906750 · Received October 10, 2023

    Report

    Report Number
    1526439-2023-01996
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNI
    Product Problem
    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. H10 ADDITIONAL NARRATIVE: 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. 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 GERMANY AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: BURKHARDT, B.W. ET AL (2021), ANTERIOR CERVICAL DISCECTOMY AND FUSION WITH A DYNAMIC TRANSLATIONAL PLATING VERSUS A RIGID CARBON FIBER REINFORCED PEEK PLATING SYSTEM ¿ A COMPARISON STUDY OF RADIOGRAPHIC PARAMETERS, BRITISH JOURNAL OF NEUROSURGERY, VOL. XX (XX), PAGES 1-5 (GERMANY). THE AIM OF THIS RETROSPECTIVE STUDY WAS TO COMPARE THE RADIOGRAPHIC FINDINGS OF PATIENTS UNDERGOING 1-3 LEVEL ACDF A RIGID CFRP PLATE AND A TRANSLATIONAL TITANIUM PLATE SYSTEM. DURING THE STUDY PERIOD, A TOTAL OF 70 PATIENTS WHO UNDERWENT A 1 TO 3 LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AT TWO TERTIARY CARE INSTITUTIONS WERE INCLUDED IN THE STUDY. THE COHORT WAS DIVIDED INTO TWO GROUPS BASED UPON THE PLATING SYSTEM USED (TRANSLATIONAL VERSUS RIGID PLATE). ALL SURGERIES IN THE TRANSLATION PLATE (GROUP 1; N=38 PATIENTS; 15 WERE FEMALES) WERE PERFORMED USING A TRANSLATIONAL PLATE WITH FEATURES OF INTERNAL SHORTENING (SWIFT, DEPUY SYNTHES, RAYNHAM, MA, USA) WHICH WAS PLACED AND FIXED WITH SELF-TAPPING FIXED ANGLE SCREWS. WHILE PROCEDURES IN THE RIGID PLATE (GROUP 2; N=32 PATIENTS; 21 WERE FEMALES) WERE PERFORMED USING A RIGID PLATE (ICOTEC AG, ALTSTÄTTEN, SWITZERLAND). THE MEAN AGE FOR GROUP 1 WAS 56.3 ± 12.4 YEARS AND FOR GROUP 2 WAS 53.8 ± 11.4 YEARS. THE MEAN FOLLOW-UP TIME FOR GROUP 1 WAS 12.8 ± 6.6 MONTHS (RANGE 6.2-24.8 MONTHS) AND FOR GROUP 2 WAS 12.1 ± 5.0 MONTHS (RANGE 6.1-24.0 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: GROUP 1: 3 PATIENTS HAD NON-UNION WHICH OCCURRED IN TWO 2 AND ONE 3-LEVEL FUSION CONSTRUCT. THERE WERE TWO INSTANCES OF 1-2MM SCREW PULLOUT FOLLOWING A 1-LEVEL AND TWO INSTANCES FOLLOWING A 3-LEVEL PROCEDURE. REVISION SURGERY WAS NOT PERFORMED IN ANY OF CASES. 6 PATIENTS HAD WORSENING OF OSSIFICATION AT THE CRANIAL ADJACENT SEGMENTS. 8 PATIENTS HAD WORSENING OF OSSIFICATION AT THE CAUDAL ADJACENT SEGMENTS. IN AN UNKNOWN NUMBER OF PATIENTS, A LOSS OF CORRECTION WAS OBSERVED, BUT WAS SIGNIFICANTLY LESS COMPARED TO GROUP 2. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT INVOLVES ONE UNK SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302309 UNKNOWN SCREWS ORTHOSIS, PEDICLE SPINAL FIXATION MNI MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK - PLATES: EAGLE PLUS.