BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 7660386 · Received July 3, 2018

    Report

    Report Number
    3007700286-2018-00055
    Event Type
    Injury
    Date Received
    July 3, 2018
    Date of Event
    February 4, 2021
    Report Date
    March 1, 2021
    Manufacturer
    SI-BONE, INC.
    Product Code
    OUR
    PMA / PMN Number
    K190230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: IN (B)(6) 2021, THE SURGEON PERFORMED AN ADDITIONAL REVISION PROCEDURE WHERE HE REMOVED A SUSPECTED LOOSE IMPLANT. HE THEN INSTALLED A NEW IMPLANT OF THE SAME TYPE PACKED WITH BONE GRAFT INTO THE EXPLANT VOID. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

    Description of Event or Problem · 0

    PREVIOUS: TTHE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2015 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT ALSO HAD THREE ILIOSACRAL SCREWS IN THE JOINT. THE PATIENT LATER PRESENTED TO A NEW SURGEON WITH COMPLAINTS OF LEFT SI JOINT PAIN. THE SURGEON DETERMINED PSEUDOARTHROSIS AND JOINT DIASTASIS OF THE LEFT SI JOINT. IN (B)(6) 2018, THE SURGEON REMOVED THE MOST CRANIAL AND MIDDLE POSITIONED IMPLANTS, REMOVED THE ILIOSACRAL SCREWS AND DECORTICATED THE JOINT. THE SURGEON THEN INSTALLED TWO NEW IFUSE IMPLANTS IN DIFFERENT POSITIONS TO HELP STABILIZE THE JOINT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. UPDATED:THE SURGEON LATER DETERMINED THAT THE SECOND IMPLANT THAT WAS ADDED IN (B)(6)2018 MAY HAVE BEEN LOOSE. IN (B)(6) 2021, THE SURGEON PERFORMED AN ADDITIONAL REVISION PROCEDURE WHERE HE REMOVED THE SUSPECTED LOOSE IMPLANT. HE THEN INSTALLED A NEW IMPLANT OF THE SAME TYPE PACKED WITH BONE GRAFT INTO THE EXPLANT VOID. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU, CERTIFICATES OF ANALYSIS AND FMEAS, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS PSEUDOARTHROSIS AND JOINT DIASTASIS OF THE SI JOINT. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI/GTIN NUMBERS: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7060-90, LOT# 152790, MFD. 02/27/2013, EXP. 2018-02-27, (B)(4). 2ND (SECOND): IFUSE IMPLANT, P/N 7050-90, LOT# 222225, MFD. 10/20/2014, EXP. 2019-10-20, (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2015 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT ALSO HAD THREE ILIOSACRAL SCREWS IN THE JOINT. THE PATIENT LATER PRESENTED TO A NEW SURGEON WITH COMPLAINTS OF LEFT SI JOINT PAIN. THE SURGEON DETERMINED PSEUDOARTHROSIS AND JOINT DIASTASIS OF THE LEFT SI JOINT. IN (B)(6) 2018, THE SURGEON REMOVED THE MOST CRANIAL AND MIDDLE POSITIONED IMPLANTS, REMOVED THE ILIOSACRAL SCREWS AND DECORTICATED THE JOINT. THE SURGEON THEN INSTALLED TWO NEW IFUSE IMPLANTS IN DIFFERENT POSITIONS TO HELP STABILIZE THE JOINT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500765 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. 7055M-90 2611581

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R