Our oem distribution rep stated "xtant medical has received a product complaint from the streamline tl spinal fixation system, in which it was reported that two pedicle screw implants (01-pa-65-45, lots 381268 and 380862) were identified as broken, which required a revision procedure.Xtant medical has initiated complaint (b)(4) on the issue.Attached is the imaging provided by the complaint source.Below is relevant information provided by the complaint source, please let me know if you have any questions or concerns, appreciate the assistance.Commentary provided: patient was implanted (b)(6) 2023, on (b)(6) 2023 patient came in and reports 95% improved and was pleased with surgery result.On approximately (b)(6) 2024 a strange squeaking noise began.On (b)(6) 2024 ct scan shows vertical nondisplaced fractures through the bilateral s1 pedicle screws at both osseous entry points.Index procedure performed (b)(6) 2023, revision procedure performed (b)(6) 2024".
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