Device was not returned to resolve surgical for inspection.Batch information remains unknown at this time.Multiple attempts were made to gather data from the rep on the patient.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, d6b, d7b g5, g7, g8 h2, h7, h9, h10.
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Our distribution partner depuy synthese reported that "dps rep, nilabja dutta, states "it was reported that on an unknown date, the patient underwent an elective c3-6 anterior cervical acdf.A screw in the bottom of the construct started to back out.Patient underwent an elective acdf c 3-6".".
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