BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: ZERO-P

    MDR report key: 15182793 · Received August 8, 2022

    Report

    Report Number
    8030965-2022-05626
    Event Type
    Injury
    Date Received
    August 8, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. 510K: THIS REPORT IS FOR AN UNKNOWN DEVICE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CHEN GUANGMEI (2020), PERIOPERATIVE NURSING CARE OF PATIENTS WITH CERVICAL DISC HERNIATION UNDERGOING ANTERIOR DECOMPRESSION AND INTERNAL FIXATION WITH STEEL PLATE (CHINA). THE OBJECTIVE OF THIS STUDY IS TO EXPLORE THE PERIOPERATIVE NURSING METHODS AND EFFECTS OF ANTERIOR DECOMPRESSION AND PLATE INTERNAL FIXATION IN THE TREATMENT OF CERVICAL DISC HERNIATION. FROM MAY 2018 TO DECEMBER 2019, 85 PATIENTS WITH CERVICAL DISC HERNIATION UNDERWENT ANTERIOR DECOMPRESSION AND PLATE INTERNAL DECOMPRESSION. THE PATIENTS WERE DIVIDED INTO 2 GROUPS; OBSERVATION GROUP (N=42) AND THE CONTROL GROUP (N=43). THE OBSERVATION GROUP CONSISTED OF 23 MALES AND 19 FEMALES WITH THE AGE RANGE FROM 35-67 YEARS. TH E CONTROL GROUP CONSISTED OF 22 MALES AND 21 FEMALES WITH AN AGE RANGE FROM 33-65 YEARS. ALL PATIENTS WERE TREATED WITH ANTERIOR DECOMPRESSION PLATE (JOHNSON & JOHNSON, ZERO P. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: (N=5) SCREW LOOSENING, (N=1) BROKEN SCREW. THIS REPORT IS FOR UNK - SCREWS: ZERO-P. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297564 UNK - SCREWS: ZERO-P THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other