Catalog Number 23310000S |
Device Problem
Malposition of Device (2616)
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Patient Problems
Perforation (2001); Hip Fracture (2349)
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Event Date 08/15/2023 |
Event Type
Injury
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Manufacturer Narrative
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Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device discarded.
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Event Description
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As reported: "t2alphagt was used in the recom mode on (b)(6) 2023 for a subtrochanteric fracture of the femur.After surgery, dr confirmed cutout by both lag screws at femoral head when postoperative follow-up.Removal surgery was done at (b)(6) 2023.The dr felt that the set screws seemed to be loosely fastened to the lag screws during removal surgery.".
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Manufacturer Narrative
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The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.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.If device is returned or any further information is provided, the investigation report will be reassessed.
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Event Description
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As reported: "t2alphagt was used in the recom mode on (b)(6) 2023 for a subtrochanteric fracture of the femur.After surgery, dr confirmed cutout by both lag screws at femoral head when postoperative follow-up.Removal surgery was done at (b)(6) 2023.The dr felt that the set screws seemed to be loosely fastened to the lag screws during removal surgery.".
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Search Alerts/Recalls
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