Model Number 176645 |
Device Problem
Failure to Align (2522)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during a device follow-up, the device had a quality issue and the dissect clamps are not lining up properly.There was no patient involvement.
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Manufacturer Narrative
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Additional information: evaluation summary: post market vigilance (pmv) led an evaluation of six devices.No abnormalities were found during visual inspection and functional testing of the returned product.Jaw alignment were found to be within specification.A review of the device history record (dhr) indicates the product was released meeting all quality release specifications at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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