BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 9207860 · Received October 18, 2019

    Report

    Report Number
    3007700286-2019-00111
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    September 23, 2019
    Report Date
    October 14, 2019
    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 · 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 ALLERGIC REACTION TO TRACE METALS. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI/GTIN NUMBERS: RIGHT SIDE OF STAGED BILATERAL: 1ST (SUPERIOR): IFUSE-3D IMPLANT, P/N 7070M-90, LOT# 2585522, MFD. 04/04/17, EXP. 2022-04-04, GTIN (B)(4). 2ND (MIDDLE): IFUSE-3D IMPLANT, P/N 7060M-90, LOT# 2591271, MFD. 06/26/17, EXP. 2022-06-26, GTIN (B)(4). 3RD (INFERIOR): IFUSE-3D IMPLANT, P/N 7045M-90, LOT# 2591241, MFD. 06/13/17, EXP. 2022-06-13, GTIN (B)(4). LEFT SIDE OF STAGED BILATERAL: 1ST (SUPERIOR): IFUSE-3D IMPLANT, P/N 7060M-90, LOT# 2611651, MFD. 08/02/17, EXP. 2022-08-02, GTIN (B)(4). 2ND (MIDDLE): IFUSE-3D IMPLANT, P/N 7055M-90, LOT# 2591263, MFD. 06/29/17, EXP. 2022-06-29, GTIN (B)(4). 3RD (INFERIOR): IFUSE-3D IMPLANT, P/N 7050M-90, LOT# 2591254, MFD. 08/07/17, EXP. 2022-08-07, GTIN (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD STAGED BILATERAL SI JOINT ARTHRODESIS WITH THE RIGHT SIDE BEING PERFORMED IN (B)(6) 2017 AND THE LEFT IN (B)(6) 2017. THREE IMPLANTS WERE INSTALLED ON EACH OCCASION. THE PATIENT LATER COMPLAINED OF ITCHING ALL OVER HIS BODY. THE PATIENT SAID HE HAD A SIMILAR ALLERGIC REACTION TO PREVIOUS UNRELATED CERVICAL IMPLANTS THAT RESOLVED UPON THEIR REMOVAL, BUT HE DID NOT TELL THE SURGEON THAT BEFORE EITHER OF THE SI JOINT ARTHRODESIS PROCEDURES. IN (B)(6) 2019, THE SURGEON REMOVED ALL THREE RIGHT SIDE IMPLANTS DUE TO SUSPECTED METAL ALLERGIES AND WILL REMOVE THE LEFT SIDE IMPLANTS LATER. THE IMPLANTS WERE REMOVED WITH CHISELS AS THEY WERE SOLIDLY FIXED IN BONE. THE SURGEON DID NOT INDICATE THAT THE IMPLANTS WERE LOOSE OR MALPOSITIONED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001234 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other