Device Problem
Mechanical Problem (1384)
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Patient Problem
No Information (3190)
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Event Date 07/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product not returned to manufacturer.
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Event Description
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It was also reported that the driver (unk driver) may be malfunction, it did not hold the implant.It was also reported that the implant (cm3110) fell down on the floor during the procedure.There is no reported impact or harm to the patient.
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Manufacturer Narrative
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No product was returned for inspection.No device lot number was provided so a device history record review and a complaint history review could not be performed.Without the returned product, there is not enough evidence to form a conclusion on the reported event.Therefore, the complaint is non-verifiable.A root cause cannot be determined.
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Event Description
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No further event information available at the time of this report.
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Event Description
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It was reported that the driver (unk driver) may be malfunction, it did not hold the implant, as it was a little bit loose, hard to latch.The implant was not latched properly.It was also reported that the implant (ct3113) fell down on the floor during the procedure.The procedure was completed with another driver.There is no reported impact or harm to the patient.
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Manufacturer Narrative
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The following sections have been updated: date of this report.Updated event description.Contact office.Date received by manufacturer.Checked "follow-up".Checked follow-up type.Added manufacturer narrative.
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Search Alerts/Recalls
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