BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN REGENETEN BIOINDUCTIVE IMPLANT SYSTEM INSTR

    MDR report key: 23097333 · Received September 19, 2025

    Report

    Report Number
    3003604053-2025-00045
    Event Type
    Injury
    Date Received
    September 19, 2025
    Report Date
    September 19, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    ORQ
    PMA / PMN Number
    K140300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). ARTICLE: LING, S. K. K., KO, V. M. C., ZUO, Y., CHOW, E. M. W., LIYEUNG, L., & YUNG, P. S. H. (2024). CASE SERIES ON BIOINDUCTIVE COLLAGEN SCAFFOLD AUGMENTED TENDON REPAIR FOR ACUTE ACHILLES TENDON RUPTURES WITH BACKGROUND TENDINOPATHY. JOURNAL OF ORTHOPAEDICS, TRAUMA AND REHABILITATION, 22104917251343231. H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH A REVIEW OF CLINICAL EVIDENCE FROM LITERATURE SOURCES THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "CASE SERIES ON BIOINDUCTIVE COLLAGEN SCAFFOLD AUGMENTED TENDON REPAIR FOR ACUTE ACHILLES TENDON RUPTURES WITH BACKGROUND TENDINOPATHY", 1 PATIENT HAD A SUTURE ABSCESS AFTER A ACHILLES TENDON RUPTURE TREATMENT PROCEDURE USING A REGENETEN IMPLANT DEVICE. PATIENT REQUIRED A COURSE OF ORAL AUGMENTIN AND ALTERNATE-DAY NURSE DRESSING. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2022556 UNKN REGENETEN BIOINDUCTIVE IMPLANT SYSTEM INSTR MESH, SURGICAL, DEPLOYER ORQ SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O