TORNIER INC UNKNOWN FUTURA CONICAL SUBTALAR CSI IMPLANT LEFT FOOT; PROSTHESIS, TOE, HEMI-, PHALANGEAL
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Catalog Number UNK_WTB |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Deformity/ Disfigurement (2360)
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Event Date 11/04/2022 |
Event Type
Injury
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Manufacturer Narrative
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The reported event regarding persistent symptomatic flatfoot deformity, but without pain at the sinus tarsi, could not be confirmed since the device(s) were not returned for evaluation and no other additional information was received from the clinical site.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause. 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 post market clinical team has conducted a follow-up report on ¿radiographic clinical observational study on patients treated for flat foot ¿.The study was conducted at ¿irccs istituto ortopedico galeazzi, italy¿.The report is associated with the stryker ¿futura conical subtalar implant system (csi) ¿ and includes an analysis of the clinical data that was collected on 40 patients.The cases in the study range from january 2005 to may 2016.The report indicates that 1 patient experienced persistent symptomatic flatfoot deformity, but without pain at the sinus tarsi.
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Search Alerts/Recalls
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