BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK BIO PUTTY/PASTE: PROSIDYAN

    MDR report key: 22471478 · Received July 10, 2025

    Report

    Report Number
    3011015097-2025-00001
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Manufacturer
    PROSIDYAN, INC
    Product Code
    MQV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    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. H11 ADDITIONAL NARRATIVE: CORRECTED: H1 (TYPE OF REPORTABLE EVENT), H6 (MEDICAL DEVICE PROBLEM CODE). H6: UPDATED PE CODE FROM FUNCTIONAL SUBSIDENCE TO FUNCTIONAL MIGRATION/BACKOUT/PULL-OUT. H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. INVESTIGATION SUMMARY: 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. 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 COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE ARTICLE HAS BEEN REVIEWED: ISABEL S, SUZANNE K, DAVID HK, BRIAN K. BIOACTIVE GLASS PUTTY AS A STAND-ALONE INTERBODY GRAFT CHOICE IN XLIF: RADIOGRAPHIC AND CLINICAL OUTCOMES. HTTPS://WWW.PROSIDYAN.COM/FIBERGRAFT-BG-PUTTY/ AND HTTP://JSS.AMEGROUPS.COM/ARTICLE/VIEW/3512/HTML. OBJECTIVE/METHODS/STUDY DATA: THIS COHORT STUDY AIMS TO ASSESS THE RADIOGRAPHIC AND CLINICAL PERFORMANCE OF FIBERGRAFT¿ (PROSIDYAN, NEW PROVIDENCE, NJ, USA) - A BIOACTIVE GLASS PUTTY - AS A STAND-ALONE GRAFT CHOICE IN LLIF. A TOTAL OF 16 PATIENTS (62.5% FEMALE) WITH A MEAN AGE OF 64.8 YEARS HAD LATERAL LUMBAR INTERBODY FUSION (LLIF). FIBERGRAFT¿ (PROSIDYAN, NEW PROVIDENCE, NJ, USA), THE GRAFT USED IN OUR COHORT OF PATIENTS, IS A PUTTY MADE UP OF MICROSCOPIC FIBERS OF BIOACTIVE GLASS. FUSIONS WERE CLASSIFIED AS SOLID, NEARLY SOLID, AND NOT FUSED. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES BIOACTIVE GLASS FIBERGRAFT. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK BIO PUTTY/PASTE: PROSIDYAN (QTY 5). -5 CASES OF PARTIALLY FUSED OR NOT FUSED AT YEAR AFTER SURGERY. NO INTERVENTION MENTIONED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK BIO PUTTY/PASTE: PROSIDYAN (QTY 14). -5 CASES OF SUBSIDENCE EVENTS IN SOLID FUSION GROUP. NO INTERVENTION MENTIONED. -9 CASES OF SUBSIDENCE EVENTS IN NEARLY SOLID OR NOT FUSED. NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855742 UNK BIO PUTTY/PASTE: PROSIDYAN FILLER, BONE VOID, CALCIUM COMPOUND MQV PROSIDYAN, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention