BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BIO PUTTY/PASTE: PROSIDYAN

    MDR report key: 23839467 · Received December 18, 2025

    Report

    Report Number
    3011015097-2025-00010
    Event Type
    Injury
    Date Received
    December 18, 2025
    Manufacturer
    PROSIDYAN, INC
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL MANUFACTURER 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: INVESTIGATION SUMMARY: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION, THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS REQUIRED AT THIS TIME. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, 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 REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING: EVALUATION OF HEALTHCARE OUTCOMES OF PATIENTS TREATED WITH DEPUY SYNTHES FIBERGRAFT BG PUTTY. REPORTED COMPLICATIONS AS PER ICD-10 PROCEDURE CODE OR CPT CODE AND ICD-10 DIAGNOSIS CODE: OFF-LABEL DEFINED BASED ON THE PRESENCE OF A DIAGNOSIS CODE RELATED TO THE FOLLOWING CONTRAINDICATIONS RECORDED DURING THE INDEX EPISODE OF CARE: ACTIVE OR UNTREATED INFECTION; - SIGNIFICANT VASCULAR IMPAIRMENT PROXIMAL TO THE BONY VOID OR GAP; METABOLIC OR SYSTEMIC BONE DISORDERS THAT AFFECT BONE OR WOUND HEALING. SPD COMPLAINT: IP UNK BIO PUTTY/PASTE: PROSIDYAN FOR 0-90 DAYS POST-INDEX. QTY 24 TOTAL REOPERATIONS (QTY 10 IN SPINE-ON LABEL, QTY 14 SPINE-OFF LABEL). IP UNK BIO PUTTY/PASTE: PROSIDYAN FOR 0-730 DAYS POST-INDEX. QTY 226 TOTAL REVISIONS (QTY 141 IN SPINE-ON LABEL, QTY 85 SPINE-OFF LABEL). QTY 57 NONUNION/PSEUDOARTHROSIS (QTY 37 IN SPINE-ON LABEL, QTY 20 SPINE-OFF LABEL). QTY 78 INFECTIONS (QTY 36 IN SPINE-ON LABEL, QTY 42SPINE-OFF LABEL). SYN COMPLAINT: IP UNK BIO PUTTY/PASTE: PROSIDYAN FOR 0-90 DAYS POST-INDEX. QTY 1 TOTAL REOPERATIONS (QTY 1 APPENDICULAR SKELETON-ON LABEL, QTY 0 APPENDICULAR SKELETON-OFF LABEL). IP UNK BIO PUTTY/PASTE: PROSIDYAN FOR 0-730 DAYS POST-INDEX. QTY 64 TOTAL REVISIONS (QTY 36 APPENDICULAR SKELETON-ON LABEL, QTY 28 APPENDICULAR SKELETON-OFF LABEL). QTY 38 NONUNION/MALUNION (QTY 19 APPENDICULAR SKELETON-ON LABEL, QTY 19 APPENDICULAR SKELETON-OFF LABEL). QTY 33 INFECTIONS (QTY 14 APPENDICULAR SKELETON-ON LABEL, QTY 19 APPENDICULAR SKELETON-OFF LABEL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259336 UNK BIO PUTTY/PASTE: PROSIDYAN FILLER, BONE VOID, CALCIUM COMPOUND MQV PROSIDYAN, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention