Model Number SD980.016 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
Physical Asymmetry (4573)
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Event Date 01/18/2024 |
Event Type
Injury
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Manufacturer Narrative
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The investigation is ongoing.
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Event Description
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It was reported that the patient encountered a relapse postoperatively resulting in a malocclusion and requiring a revision surgery for the lower jaw.
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Event Description
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It was reported that the patient encountered a relapse postoperatively resulting in a malocclusion and requiring a revision surgery for the lower jaw.
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Manufacturer Narrative
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The investigation concluded that the device met the specifications.The root cause could be related to the patient-specific anatomy - the right condyle, which somehow forced the jaw to move backward.However, it cannot be confirmed without a post-operatively file.
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Search Alerts/Recalls
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