| Catalog Number |
650705550001 |
| Medical Device Problem Code |
Device Dislodged or Dislocated (2923)
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| Health Effect - Clinical Code |
No Clinical Signs, Symptoms or Conditions (4582)
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Type of Reportable Event
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Malfunction
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Event or Problem Description
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between january 1- march 31, 2026.This report summarizes 3 malfunction events(s), where it was reported the devices experienced cot falsely engages into fastener.No adverse consequence or clinically relevant delay in treatment was reported.
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Additional Manufacturer Narrative
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This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.2 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.Evaluation results findings (components/results) 1 device: fastener / device migration 1 device: chassis/frame / device migration 1 device is pending evaluation.Evaluation results findings (components/results) 1 device: insufficient information / results pending completion of investigation there was no remedial action taken.This device is not labeled for single use.
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Search Alerts/Recalls
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