Model Number SC-1200 |
Device Problem
Material Separation (1562)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 03/21/2018 |
Event Type
Injury
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Manufacturer Narrative
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Device evaluation indicated that the complaint was confirmed.The setscrew from port c was missing.It was reported that the setscrew fell out of ipg in the operation room when the tech was trying to lessen for port plug.The device functionality test was performed to ensure the device integrity.No other anomalies were found.
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Event Description
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A report was received that the product was return due to a setscrew fell out of ipg while the tech was trying to lessen for port plug.It was unknown if the missing setscrew was removed or left inside the patient's body.
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Manufacturer Narrative
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Additional information was received that the setscrew fell on the ground and was never near the patient's body.
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Event Description
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A report was received that the product was returned due to a setscrew fell out of ipg while the tech was trying to lessen for port plug.It was unknown if the missing setscrew was removed or left inside the patient's body.
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Search Alerts/Recalls
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