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Catalog Number UNK_SEL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/01/2019 |
Event Type
Injury
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Event Description
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The manufacturer became aware of a literature published by the guy¿s and st.Thomas¿ nhs foundation trust, united kingdom.The title of this report is ¿first metatarsophalangeal fusion using joint specific dorsal plate with interfragmentary screw augmentation: clinical and radiological outcomes ¿, published on april 01, 2019, which is associated with the stryker ¿anchorage plating system¿.The article can be found at https://doi.Org/10.1016/j.Fas.2017.09.005.This report includes an analysis of the clinical data that was collected on 38 patients, and the cases in this study range from august 2013 to november 2016 during the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 1 patient experienced prominent distal of the plate tip over the proximal phalanx, which required plate removal.The report states, ¿ the distal part of the plate was prominent, which we feel was related to technical error.The low-profile plate shall only position appropriately if the cross-screw countersink is prepared satisfactorily.In this case, the countersink was not deep enough to seat the plate and thus it became prominent distally.This was acknowledged as a technical error and avoided subsequently.¿.
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Manufacturer Narrative
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This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged prominent distal, requiring revision, could not be confirmed, since the device was not returned for evaluation and no other additional information was received from the author.More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
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Manufacturer Narrative
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Correction: please refer to h1 summary report & h1 number of events summarized please note the h1 summary report tab and h1 number of events summarized tab were selected in error.This complaint has been generated based on findings discovered during the post-market surveillance literature review.The alleged event of prominent distal of the plate tip over the proximal phalanx, which required plate removal, could be confirmed from the available information and x-ray in the literature study.With an available x-ray, a formal medical opinion was sorted which states that there can be potential intra- or postoperative causes plausible as underlying root causes.However, if the treating surgeons assess the underlying cause as the countersink was not deep enough to seat the plate and thus it became prominent distally, then this should also be assumed to be the cause until proven otherwise.So, the primary root cause can be attributed to as user-related.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
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Event Description
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The manufacturer became aware of a literature published by the guy¿s and st.Thomas¿ nhs foundation trust, united kingdom.The title of this report is ¿first metatarsophalangeal fusion using joint specific dorsal plate with interfragmentary screw augmentation: clinical and radiological outcomes ¿, published on april 01, 2019, which is associated with the stryker ¿anchorage plating system¿.The article can be found at https://doi.Org/10.1016/j.Fas.2017.09.005.This report includes an analysis of the clinical data that was collected on 38 patients, and the cases in this study range from august 2013 to november 2016.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 1 patient experienced prominent distal of the plate tip over the proximal phalanx, which required plate removal.The report states, ¿ the distal part of the plate was prominent, which we feel was related to technical error.The low-profile plate shall only position appropriately if the cross-screw countersink is prepared satisfactorily.In this case, the countersink was not deep enough to seat the plate and thus it became prominent distally.This was acknowledged as a technical error and avoided subsequently.¿.
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Search Alerts/Recalls
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