Catalog Number LV01548 |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Event Description
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It was reported that the tip of the driver broke while tightening a cross connector during the procedure.The tip was retrieved and the standard cross connector wrench was used to complete the case without reported patient harm.
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Event Description
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It was reported that the tip of the driver broke while tightening a cross connector during the procedure.The tip was retrieved and the standard cross connector wrench was used to complete the case without reported patient harm.
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
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Event Description
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It was reported that the tip of the driver broke while tightening a cross connector during the procedure.The tip was retrieved and the standard cross connector wrench was used to complete the case without reported patient harm.
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Manufacturer Narrative
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The complaint is confirmed for one (1) of one (1) 3mm cross connector driver (pn: lv01548) for the failure of being fractured.The severity of this event is (b)(4).Medical records were not provided for review.Potential cause: cause can't be established since there is no information available regarding how the driver was being used or handled at the time of the damage.Complaint history: there were zero (0) other complaints for similar events (fracture) related to the same part number in the 12 months leading up to the notification date through to the present.Dhr review and related actions: a dhr review can't be performed since the lot number was not provided.No actions required.This event is not related to any current actions or recalls or product holds.Device use and compatibility: this device is used for treatment.Reported event is not related to a combination of product lines; therefore a compatibility review is not applicable.
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Search Alerts/Recalls
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