BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT

    MDR report key: 2551185 · Received April 27, 2012

    Report

    Report Number
    3005099803-2012-01699
    Event Type
    Injury
    Date Received
    April 27, 2012
    Report Date
    April 2, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MBI
    PMA / PMN Number
    K971139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME, INITIALLY REPORTED: REPLIFORM SYNTHETIC MESH, CORRECTION: BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT. COMMON DEVICE NAME: INITIALLY REPORTED: MESH, SURGICAL, POLYMERIC, CORRECTION: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE. PRODUCT CODE: INITIALLY REPORTED: FTL, CORRECTION: MBI. (B)(4). PMA# OR 510K#: INITIALLY REPORTED: K963226, CORRECTION: K971139.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROTEGEN REPLIFORM SYNTHETIC MESH WAS USED FOR A PROCEDURE (DATE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED COMPLICATIONS, BUT THE EXACT NATURE AND DATE OF ONSET OF THE COMPLICATIONS ARE UNKNOWN. ALL OTHER INFORMATION IS UNKNOWN AND REPORTEDLY UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROTEGEN REPLIFORM SYNTHETIC MESH WAS USED FOR A PROCEDURE (DATE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED COMPLICATIONS BUT THE EXACT NATURE AND DATE OF ONSET OF THE COMPLICATIONS ARE UNKNOWN. ALL OTHER INFORMATION IS UNKNOWN AND REPORTEDLY UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROTEGEN REPLIFORM SYNTHETIC MESH WAS USED FOR A PROCEDURE (DATE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED COMPLICATIONS BUT THE EXACT NATURE AND DATE OF ONSET OF THE COMPLICATIONS ARE UNKNOWN. ALL OTHER INFORMATION IS UNKNOWN AND REPORTEDLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI BOSTON SCIENTIFIC - SPENCER UNK395

    Patients

    Seq Age Sex Outcome Treatment
    1 Other