The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.
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The manufacturer became aware of a literature published by (b)(6).The title of this report is ¿medial migration of lag screw with intrapelvic dislocation in gamma nailing-a unique problem? a report of 2 cases¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at https://doi.Org/10.1097/bot.0b013e3181a4eeb2.Within that publication which included 2 patients, post-operative complications were reported.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses implant disengagement with lag screw migration into the pelvis which was treated with a cemented bipolar prosthesis.The report states: ¿at 6 months, radiographs showed a completely disengaged implant (fig.7).The screw had migrated medially into the pelvis with its tip located directly adjacent to the dorsal wall of the bladder (fig.8).The patient was treated with a cemented bipolar prosthesis.¿.
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