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.
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The manufacturer became aware of a pmcf conducted by (b)(6) university.The title of this report is ¿multi-center observational prospective unblinded case-control study to evaluate the effect of the distal targeting system for the gamma 3 long nail on radiation exposure and time for distal screw placement¿ published on june 30, 2021, which is associated with the stryker ¿gamma3 nailing¿ system.This report includes research done on 58 patients between the period december, 2019 and december, 2020.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 one patient in the pc cohort (1/29) sustained cutout of the lag screw and underwent conversion arthroplasty at 4 months postoperatively.
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