Model Number CI24M |
Device Problem
Malposition of Device (2616)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/14/2007 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on november 15, 2022.
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Event Description
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Per the clinic, the implant was initially incorrectly positioned.The device was explanted (b)(6) 2007 and was re-implanted in 2018.
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Manufacturer Narrative
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Correction: the previous or initial mdr submitted on november 15, 2022 was filed incorrectly.No device explantation has occurred.Recipient only underwent revision surgery on (b)(6) 2007, to reposition the device.This report is submitted on january 03, 2022.
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Manufacturer Narrative
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Correction: the date of awareness is september 29, 2022.This report is submitted on january 19, 2023.
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Search Alerts/Recalls
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