BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1414629 · Received July 15, 2009

    Report

    Report Number
    2522801-2009-00020
    Event Type
    Other
    Date Received
    July 15, 2009
    Date of Event
    June 1, 2009
    Report Date
    July 15, 2009
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THE DATE OF THIS REPORT, THE SURGICAL SPECIALTIES FACILITY IN (B)(6) HAS NOT RECEIVED ANY COMPLAINT PRODUCT FOR EVALUATION. TWO (2) OTHER QUILL SRS PRODUCTS WERE ALSO REPORTED. THE PRODUCT INFO IS AS FOLLOWS: MODEL/CATALOG# RA-1029Q. LOT# UNK. EXPIRATION DATE: UNK. DEVICE MANUFACTURE DATE: UNK. 510(K)#: K051609. MODEL/CATALOG#: YA-1022Q. LOT#: M587430-M591840. EXPIRATION DATE: 01/31/2011 - 02/28/2011. DEVICE MANUFACTURE DATE: 01/2009 - 02/2009. 510(K)#: K072028. METHOD: THE DEVICES WERE NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. FURTHERMORE, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD (DHR) WERE REVIEWED FOR THE FINISHED GOOD LOT NUMBERS REPORTED. NO RELEVANT FINDINGS WERE NOTED DURING THIS REVIEW. ONE LOT WAS REPORTED AS "UNKNOWN". A DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED FOR THIS LOT. RESULTS: THE DEVICES WERE NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. (B)(4). YA-10225Q, QUILL SRS 2-0 MONODERM. RA-1031Q, QUILL SRS #1 PDO. RA-1029Q, QUILL SRS -0- PDO.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT FIVE (5) PTS EXPERIENCED WOUND DEHISCENCE FOLLOWING CERVICAL AND SPINAL FUSION PROCEDURES USING #1 PDO FOR FASCIAL CLOSURE, -0- PDO FOR SUBCUTICULAR CLOSURE AND 2-0 MONODERM FOR SUPERFICIAL LAYER CLOSURE. APPROXIMATELY TWO (2) WEEKS POST OPERATIVELY, PTS EXPERIENCED WOUND DEHISCENCE. THREE (3) PTS REQUIRED RECLOSURES. THE SURGEON STATES THAT THE MONODERM WAS NOT LASTING LONG ENOUGH FOR DESIRED WOUND STRENGTH AND THAT HE HISTORICALLY WOULD CLOSE WITH VICRYL PRIOR TO TRYING THE MONODERM. VICRYL HAS A LONGER DURATION PROFILE THAN MONODERM. NOTE: THE IFU FOR THE MONODERM MATERIAL STATES IN VIVO STRENGTH AT SEVEN (7) DAYS 67% AND AT FOURTEEN (14) DAYS 27%. THE SURGEON HAS REVERTED BACK TO USING VICRYL FOR SUPERFICIAL LAYER CLOSURE. REPORTABLE EVENT SECONDARY TO SURGICAL INTERVENTION AND USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE WITH NEEDLE NEW SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) RA-1031Q M443470

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE MADE AVAILABLE.