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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Non-union Bone Fracture (2369); Skin Disorders (4543)
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Event Date 05/25/2022 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference (b)(4).Article cite: conway, j.D., elhessy, a.H., galiboglu, s., patel, n., & gesheff, m.G.(2022).Efficacy of infection eradication in antibiotic cement-coated intramedullary nails for fracture-related infections, nonunions, and fusions.Antibiotics (basel, switzerland), 11(6), 709.Https://doi.Org/10.3390/antibiotics11060709.
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Event Description
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It was reported that on literature review, "efficacy of infection eradication in antibiotic cement-coated intramedullary nails for fracture-related infections, nonunions, and fusions", 7 patients (out of 111) had not achieved healed or uninfected bone or stable arthrodiesis, at the time of the study, after having a primary antibiotic cement-coated intramedullary nail procedure (accin).As reported, these patients were still under treatment for nonunion at the time of the study.The type of treatment is unknown as well as the outcome of the patients.The primary accin procedures were performed for the treatment of infected nonunions or infected arthrodeses.Patient´s outcome is unknown.No further information is available.
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Manufacturer Narrative
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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 the complaint, no further information will be provided.Consequently, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.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.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.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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Search Alerts/Recalls
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