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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Loss of Range of Motion (2032); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/01/1901 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).Analysis on the efficacies of trigen nail and philos plate in proximal humerus fractures, (b)(6) hospital.Doi: 10.3969/j.Issn.L002-0217.2021.01.008.
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Event Description
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It was reported that on literature review "analysis on the efficacies of trigen nail and philos plate in proximal humerus fractures", 1 patient suffered from subacromial impingement due to escape of bone fragment of greater tuberosity.It is unknown how the event was treated.No further information is available.
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Manufacturer Narrative
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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 article noted one patient suffered from a subacromial impingement due to escape of bone fragment of greater tuberosity.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 patient health status remains unknown.The clinical root cause of the reported event could not be further assessed.The patient outcome 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 product 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 patient condition or complication during surgery.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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Search Alerts/Recalls
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