BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVICTUS

    MDR report key: 20452536 · Received October 15, 2024

    Report

    Report Number
    2027467-2024-00124
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    September 17, 2024
    Report Date
    October 15, 2024
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    HWX
    UDI-DI
    00190376192079
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE TAP HAS NOT RETURNED FOR EVALUATION. PHOTOGRAPHS WERE PROVIDED WHICH CONFIRM THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE IDENTIFYING LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION PROVIDED, A ROOT CAUSE COULD NOT BE DETERMINED. ALPHATEC SPINE IS SUBMITTING THIS REPORT TO COMPLY WITH THE FDA REGULATIONS 21 CFR 803. ALPHATEC SPINE HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS AVAILABLE. ANY FIELD THAT IS LEFT BLANK WAS NOT KNOWN AT THE TIME OF THIS SUBMISSION. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4. LOT #: NG105220 CORRECTED INFORMATION: PRIMARY UDI #: (B)(4). D9. YES, RETURNED TO MANUFACTURER: 10/15/2024 H3. YES H6. TYPE OF INVESTIGATION: 10, 3331 INVESTIGATION FINDINGS: 3243 INVESTIGATION CONCLUSIONS: 61 DEVICE EVALUATION: VISUAL INSPECTION CONFIRMS THAT THERE IS DAMAGE TO THE DISTAL TIP OF THE TAP. PORTIONS OF THE TIP BROKE OFF ON ONE SIDE OF THE TAP. TAPS MAY BE USED DURING PEDICLE PREPARATION TO FACILITATE SCREW INSERTION. THE CANNULATION OF THE TAP (THROUGH HOLE) IS SLID OVER THE GUIDEWIRE AFTER THE SITE HAS BEEN DILATED TO THE APPROPRIATE DIAMETER. THE BONE IS THEN TAPPED TO THE DESIRED DEPTH. THE ROOT CAUSE IS LIKELY HIGH TORSIONAL AND BENDING LOADS PLACED ON THE TAP. REVIEW OF DEVICE HISTORY RECORDS SHOWED NO MANUFACTURING OR PROCESSING RELATED IRREGULARITIES. LABELING REVIEW: WARNINGS/CAUTIONS/PRECAUTIONS: RISKS IDENTIFIED WITH THE USE OF THESE DEVICES, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE DEVICE COMPONENT FAILURE, LOSS OF FIXATION/STABILIZATION, NON-UNION, VERTEBRAL FRACTURE, NEUROLOGICAL INJURY, VASCULAR OR VISCERAL INJURY. POSSIBLE ADVERSE EFFECTS: INITIAL OR DELAYED LOOSENING, DISASSEMBLY, BENDING, DISLOCATION, AND/OR BREAKAGE OF DEVICE COMPONENTS.

    Description of Event or Problem · 0

    DURING A SPINAL PROCEDURE, IT WAS REPORTED THAT THE THREADED PORTION OF THE CANNULATED TAP BROKE OFF INSIDE THE PATIENT'S VERTEBRAL BODY. IT WAS UNABLE TO BE RETRIEVED FROM THE PATIENT. THERE WAS NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295153 INVICTUS TAP, BONE HWX ALPHATEC SPINE, INC. 17109-055 00190376192079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other