(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The following sections could not be completed as the part/lot information could be any of the following: brand name ¿ lp non lock, catalog number - 131227210, or brand name - lp non lock, catalog number ¿ 131227211, or brand name - lp non lock, catalog number ¿ 131227212, or brand name - lp non lock, catalog number ¿ 131227213, or brand name - lp non lock, catalog number ¿ 131227214, or brand name - lp non lock, catalog number ¿ 131227220, or brand name - lp non lock, catalog number ¿ 131227222, or brand name¿ lock screw square, catalog number ¿ 131227114, or brand name - lock screw square, catalog number ¿ 131227115, or brand name - lock screw square, catalog number ¿ 131227116, or brand name - lock screw square, catalog number ¿ 131227118.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 05268 0001822565 - 2019 - 05269 0001822565 - 2019 - 05270 0001822565 - 2019 - 05271 0001822565 - 2019 - 05272 0001822565 - 2019 - 05274 0001822565 - 2019 - 05275 0001822565 - 2019 - 05276 0001822565 - 2019 - 05277 0001822565 - 2019 - 05278 0001822565 - 2019 - 05279.
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It was reported that the patient was undergoing a wrist fixation procedure.After implantation of the plate and screws, and running the wrist through range of motion, the plate/screw construct fell apart.Due to this, all reduction was lost, although some of the screws did stay in loosely.The surgeon wanted to start over with the same plate, but with different screws.Further, there were 3 screws that would not initially seat properly.The surgeon completed the procedure with the same plate and new screws.Attempts have been made and additional information on the reported event is unavailable at this time.
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