BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMA PTFE

    MDR report key: 25009758 · Received April 27, 2026

    Report

    Report Number
    3009681798-2026-00017
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 27, 2024
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    NBY
    UDI-DI
    00034040001240
    PMA / PMN Number
    K140415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVER A PERIOD OF APPROXIMATELY TWO MONTHS, THE REPORTER INDICATED THAT 5-7 PATIENTS UNDERGOING EXTRACTION AND SOCKET GRAFT PROCEDURES EXPERIENCED PTFE SUTURE BREAKAGE, WITH APPROXIMATELY 1-2 SUTURES AFFECTED PER PATIENT. THE FAILURES WERE OBSERVED AFTER PLACEMENT DURING THE PROCEDURE AND WERE DESCRIBED AS SUTURE THREAD SEPARATION OCCURRING AT OR NEAR THE KNOT INTERFACE, RATHER THAN KNOT UNTYING. BREAKAGE WAS CONSISTENTLY REPORTED IN THE PALATAL/LINGUAL REGION. ALL SUTURE FRAGMENTS WERE RETRIEVED WITHOUT DIFFICULTY. THE REPORTER STATED THAT STANDARD SUTURING TECHNIQUES WERE USED, INCLUDING INTERRUPTED, FIGURE-OF-8, AND HORIZONTAL MATTRESS SUTURES. THE REPORTER FURTHER INDICATED ROUTINE LONG-TERM USE OF PTFE SUTURES WITHOUT PRIOR SIMILAR OCCURRENCES. ALL PROCEDURES WERE COMPLETED WITHOUT PATIENT HARM; HOWEVER, ADDITIONAL PROCEDURAL TIME WAS REQUIRED TO REPLACE FAILED SUTURES, AND ALTERNATIVE SUTURE MATERIAL (GLYCOLON) WAS UTILIZED FOLLOWING THE FAILURES. LOT 25101630 WAS IDENTIFIED BY THE REPORTER AS BEING ASSOCIATED WITH SEVERAL OF THE REPORTED EVENTS; HOWEVER, SPECIFIC LOT-TO-PATIENT ATTRIBUTION COULD NOT BE CONFIRMED. AN ADDITIONAL RETURNED PRODUCT ASSOCIATED WITH LOT 24041802 WAS RECEIVED AND MAY BE RELATED TO SIMILAR COMPLAINTS; HOWEVER, ITS RELATIONSHIP TO INDIVIDUAL PATIENT EVENTS COULD NOT BE ESTABLISHED. THEREFORE, LOT INVOLVEMENT CANNOT BE DEFINITIVELY ATTRIBUTED TO SPECIFIC CASES. THE PRODUCT WAS RETURNED FOR EVALUATION FOR LOT NUMBER 25101630.RETAINS WERE TESTED FOR LOT NUMBER 25101630 & 24041802. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND ALL PRODUCT MET REQUIREMENTS PRIOR TO RELEASE. THERE WERE NO NONCONFORMITIES NOTED WITH THE LOT DURING PRODUCTION. THERE WERE NO NONCONFORMITIES WITH THE RAW MATERIAL USED. ALL FINISHED GOODS TESTING REQUIREMENTS WERE MET PRIOR TO RELEASE. THERE WAS NO EVIDENCE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS AND THE REPORT COULD NOT SUBSTANTIATED.THE REPORT COULD NOT BE SUBSTANTIATED AND A CAUSE FOR THE EVENT COULD NOT BE ESTABLISHED. THIS REPORT AND USE OF CATEGORICAL DEFINITIONS REQUIRED BY FDA 3500A DOES NOT CONSTITUTE AN ADMISSION BY RIVERPOINT MEDICAL OR ITS EMPLOYEES THAT RIVERPOINT MEDICAL OR ITS EMPLOYEES HAVE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. RIVERPOINT MEDICAL HAS FILED THIS INFORMATION TO COMPLY WITH THE MEDICAL DEVICE REPORTING REGULATION 21 CFR 803. IF ADDITIONAL INFORMATION IS PROVIDED TO RIVERPOINT MEDICAL REGARDING THIS EVENT, A SUPPLEMENTARY 3500A FORM WILL BE SUBMITTED AS REQUIRED BY THE FDA.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, "OVER THE PAST COUPLE OF MONTHS, THE DOCTOR WAS PERFORMING EXTRACTION AND SOCKET GRAFT PROCEDURES WHEN FIVE TO SEVEN PATIENTS AND ONE TO TWO SUTURES WOULD SEPARATE PER PATIENT BEFORE USING A DIFFERENT SUTURE MATERIAL. ALL WERE BREAKING AWAY FROM THE KNOT. IT WAS NOT SIMPLY THE KNOT COMING UNTIED. IT USUALLY HAPPENED WHEN HE WOULD PUT IN A COUPLE OF SUTURES AND WHEN HE COULD COME BACK TO CHECK AT THE END OF THE PROCEDURE THEY WOULD BE TORN AWAY FROM THE KNOT AND USUALLY ON THE PALATAL/LINGUAL AREA. HE HAS USED PTFE SUTURES FOR YEARS AND NEVER HAD ISSUES LIKE THIS. ALL PIECES WERE ABLE TO BE RETRIEVED WITHOUT ANY ISSUES. IT WAS ALWAYS THE SUTURE THREAD BREAKING AND NEVER AN ISSUE WITH THE NEEDLE. ALL PROCEDURES WERE ABLE TO BE COMPLETED BUT THERE WAS A DELAY AS HE HAD TO GO BACK AND PLACE REMOVE THE SUTURE AND PLACE ADDITIONAL SUTURES TYPICALLY GLYCON. NO PATIENTS WERE HARMED. THE TECHNIQUE IS STANDARD SUTURING TECHNIQUE, TYPICALLY USING INTERRUPTED, FIGURE-8 AND HORIZONTAL MATTRESS SUTURES MOST COMMONLY." THERE MAY BE AN ADDITIONAL LOT THAT RELATES TO THIS EVENT THAT THE CUSTOMER RETURNED THAT WAS NOT PART OF THE ORIGINAL EVENT. THIS IS LOT NUMBER 24041802 WITH EXPIRATION 03/31/29. THIS WILL BE ADDED TO OUR EVENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224820 MAXIMA PTFE SURGICAL SUTURE NBY RIVERPOINT MEDICAL LLC 112-7259 NOT CONFIRMED 00034040001240

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown