It was reported that on literature review "comparative study of dhs, pfna and intertan internal fixation in treatment of unstable femoral intertrochanteric fractures of the elderly", four (4) patients suffered from delayed healing of fracture.It is unknown how the event was treated.No further information is available.
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H3, h6: the devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the article noted 4 patients suffered from delayed healing of fracture.Patient specific clinically relevant documentation has not been provided as of the date of this medical investigation and it was communicated that there was ¿no more information¿.The current patients health status remains unknown.The clinical root cause of the reported delayed healing of fractures could not be further assessed.The patients outcomes beyond that which was documented in the article could not be determined.No further medical assessment is warranted at this time.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, procedural/user error, surgical/post operative complications, healing issues and/or patient condition.The contribution of the devices to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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