BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - RESORBABLE IMPLANTS

    MDR report key: 11962778 · Received June 8, 2021

    Report

    Report Number
    8030965-2021-04716
    Event Type
    Injury
    Date Received
    June 8, 2021
    Report Date
    May 14, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    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. 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 · 1

    THIS REPORT IS FOR AN UNK - RAPIDSORB IPS IMPLANTS/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 · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: QI, Q. ET AL. (2021), DEPLOYMENT OF A BIOABSORBABLE PLATE AS THE RIGID BUTTRESS FOR SKULL BASE REPAIR AFTER ENDOSCOPIC PITUITARY SURGERY, GLAND SURGERY, VOL. 10, NO. 3, PAGES 1010 - 1017 (CHINA). THIS STUDY AIMED TO DESCRIBE THE USE OF A BIODEGRADABLE PLATE (POLYMAX RAPID) IN SKULL BASE REPAIR OF ENDOSCOPIC ENDONASAL PITUITARY SURGERY AND TO INVESTIGATE THE CLINICAL OUTCOME AND SAFETY OF THIS NOVEL METHOD. BETWEEN JANUARY 2019 AND JANUARY 2020, 22 PATIENTS WITH PITUITARY ADENOMAS UNDERWENT ENDOSCOPIC SKULL BASE REPAIR USING A POLYMAX RAPID PLATE. THERE WERE 10 MALES AND 12 FEMALES WITH AN AVERAGE AGE OF 51.9 YEARS. THE PATIENTS WERE ALSO FOLLOWED UP BY APPOINTED CLINICIANS TO DO ROUTINE RADIOLOGICAL EXAMINATIONS AT 3, 6, AND 12 MONTHS AFTER SURGERY. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: NO. 1 - A (B)(6) YEAR-OLD FEMALE PATIENT HAD A GRADE 1 CSF LEAK. NO. 4 - A (B)(6) YEAR-OLD MALE PATIENT HAD A GRADE 1 CSF LEAK. NO. 10 - A (B)(6) YEAR-OLD FEMALE PATIENT HAD A GRADE 1 CSF LEAK. NO. 14 - A (B)(6) YEAR-OLD MALE PATIENT HAD A GRADE 1 CSF LEAK. NO. 19 - A (B)(6) YEAR-OLD FEMALE PATIENT HAD A GRADE 1 CSF LEAK. NO. 20 - A (B)(6) YEAR-OLD FEMALE PATIENT HAD A GRADE 1 CSF LEAK. 3 PATIENTS HAD NASAL STIFFNESS. 2 PATIENTS HAD TOLERABLE HEADACHES. THIS REPORT IS FOR AN UNKNOWN SYNTHES BIODEGRADABLE PLATE (POLYMAX RAPID). THIS REPORT IS FOR ONE (1) UNK - RAPIDSORB IPS IMPLANTS. THIS IS REPORT 6 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852383 UNK - RESORBABLE IMPLANTS PLATE, BONE JEY SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown