Our oem distribution rep "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-55-45, lots 378753 and 388226) were identified as broken, which required a revision procedure.Xtant medical has initiated complaint 24-024 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.Index procedure performed (b)(6) 2022, revision procedure performed (b)(6) 2024".
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"device was not returned to resolve surgical for inspection.Multiple attempts were made to gather data from the rep.No additional information or confirmation has been given that this is a pioneer surgical technologies manufactured part.The following sections of this report have been left blank due to the information being unavailable or non-applicable: a1-a6, b3, b6-b7, d6a, g5, g7-g8, h2, h7, h9-h10.
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