Internal complaint reference: (b)(4).Abalkhail, t.B., elhessy, a.H., & conway, j.D.(2022).Removal of antibiotic cement-coated interlocking nails.Journal of orthopaedic trauma, 36(6), 317-320.Doi: 10.1097/bot.0000000000002287.
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H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the attached literature review on "removal of antibiotic cement-coated interlocking nails", was reviewed.However, based on the information provided, no further information is available.Consequently, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The photos provided in the article have been interpreted within the text; therefore, no further analysis of the photos are required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event have been identified as excessive pressure on the joint, injury, procedural/user error, surgical/post operative complications, healing issues, patient condition, and/or user error.The contribution of the device 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 product involved, our investigation could not proceed.Should the device 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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