On 03feb22 accelus was informed of a complaint on a linesider non-modular standard screw.It was originally reported by the rep that an intraoperative screw head separation had occurred during the procedure.At the time, this was all the information that was available.New information was received on 11mar22.Per the complaint entry form received on 11mar22, the reported weld failure occurred during a revision procedure.The initial surgery was a 4 level plif and fixation procedure that took place on (b)(6) 2021.During a postoperative follow up visit it was noted that one of cephalad screws was loosening, as a result, the surgeon opted to revise the procedure.The revision procedure took place on (b)(6) 2022.It was noted during the revision procedure that one of the caudal screws had a separated tulip head.It is unknown if this separation occurred postoperatively or during the revision procedure.The procedure was completed by removing and replacing the loose cephalad screw and the separated caudal screw.The reported weld failure resulted in a 10 minute delay to the revision procedure.No additional patient harm was reported as a result of this occurrence.
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