BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK BIO PUTTY/PASTE: PROSIDYAN

    MDR report key: 22471905 · Received July 10, 2025

    Report

    Report Number
    3011015097-2025-00002
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    January 1, 2022
    Manufacturer
    PROSIDYAN, INC
    Product Code
    MQV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. H3, H6: 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.

    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. H11 ADDITIONAL NARRATIVE: H3, H6: 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: HYUN B, ADAIRE O, CHAMBLISS H, MARGARET M, GOERGE H, LUC F. LUMBAR INTERBODY FUSION AUGMENTED WITH A NOVEL BIOACTIVE GLASS BONE GRAFT SUBSTITUTE: SAFETY AND FUSION OUTCOMES FROM A RETROSPECTIVE COHORT STUDY. ISSLS-2022.M.ISSLS.CURRINDA.COM/SCHEDULE/SESSION/330/ABSTRACT/2919 OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS RETROSPECTIVE COHORT STUDY WAS TO EVALUATE THE FUSION AND SAFETY OUTCOMES OF A BIOACTIVE GLASS BONE GRAFT SUBSTITUTE IN LUMBAR INTERBODY FUSION (LIF) PROCEDURES PERFORMED BY A SINGLE SURGEON. BETWEEN APRIL 2017 AND APRIL 2018, A TOTAL OF 66 PATIENTS (58% FEMALE, AVERAGE AGE 65.2 YEARS). EIGHT PATIENTS DECLINED PROSPECTIVE STUDY PARTICIPATION AND 4 WERE NOT ELIGIBLE DUE TO REVISION LIF SURGERIES, RESULTING IN CT FUSION ASSESSMENT IN 54 SUBJECTS. A COMBINATION OF BIOACTIVE BONE GRAFT (FIBERGRAFT® BG PUTTY) AND AUTOGRAFT WAS USED AT EACH LIF LEVEL. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES BIOACTIVE BONE GRAFT. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK BIO PUTTY/PASTE: PROSIDYAN (QTY 1) -9.8% CASES OF LOCKED PSEUDOARTHROSIS. NO INTERVENTION MENTIONED. -1.1% CASES OF PSEUDOARTHROSIS. NO INTERVENTION MENTIONED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK BIO PUTTY/PASTE: PROSIDYAN (QTY 7) -6 CASES OF CAGE SUBSIDENCE WERE NOTED ON CT. -1 INSTANCE OF CAGE MIGRATION NOTED IN THE ADVERSE EVENT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729153 UNK BIO PUTTY/PASTE: PROSIDYAN FILLER, BONE VOID, CALCIUM COMPOUND MQV PROSIDYAN, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention