Model Number 1192 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/26/2021 |
Event Type
malfunction
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Event Description
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Related manufacturer report 1627487-2021-15187.It was reported that during a procedure reported in related manufacturer report 1627487-2021-15180 and related manufacturer report 1627487-2021-15181, upon attempting to explant, the anchor was broken, and fragments were left in the patient.The distal end of the anchor remains implanted in the procedure.No additional information is anticipated.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Search Alerts/Recalls
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