WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN GRAVITY SYNCHFIX SYNDESMOSIS FIXATION DEVICE; PLATE, FIXATION, BONE
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Catalog Number UNK_WWA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Non-union Bone Fracture (2369)
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Event Date 07/21/2022 |
Event Type
Injury
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Event Description
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The post market clinical team has conducted a follow-up report on ¿a retrospective data collection of fracture fixation, revision procedures, joint fusion, and bone reconstruction in the foot and toes with the ortholoc 3di hallux plating system¿.The study was conducted at 'cooper university hospital, cooper bone and joint institute, usa'.The report is associated with the stryker ¿ortholoc 3di hallux plating system¿ and includes an analysis of the clinical data that was collected on 46 patients.The cases in the study range from january 1, 2010, to august 31, 2021.The report indicates that 5 patients experienced nonunion.
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Manufacturer Narrative
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The reported event of nonunion 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 ¿a retrospective data collection of fracture fixation, revision procedures, joint fusion, and bone reconstruction in the foot and toes with the ortholoc 3di hallux plating system¿.The study was conducted at (b)(6) hospital, (b)(6) institute, usa'.The report is associated with the stryker ¿ortholoc 3di hallux plating system¿ and includes an analysis of the clinical data that was collected on 46 patients.The cases in the study range from january 1, 2010, to august 31, 2021.The report indicates that 5 patients experienced nonunion.
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Manufacturer Narrative
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Please note correction to product code and common device name.
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Search Alerts/Recalls
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