Model Number DIAM.36MM TILTED 10° FOR 29MM BASEPLATE |
Device Problem
Device Difficult to Setup or Prepare (1487)
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Patient Problems
Awareness during Anaesthesia (1707); Failure of Implant (1924)
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Event Date 03/13/2020 |
Event Type
Injury
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Manufacturer Narrative
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This is the initial report submitted regarding this surgical event and medical device.
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Event Description
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The glenoidsphere could not be implanted as the central screw was blocked.Another glenoid sphere was used and the surgery was completed with a delay.
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Manufacturer Narrative
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This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.
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Search Alerts/Recalls
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