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Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).510k: this report is for an unk - plates: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a surgery.During the surgery, it was noticed that the screw does not thread into the plate.It was unknown if the surgery completed successfully.There were no patient consequences.Concomitant devices reported: unknown plate (part# unknown, lot# unknown, quantity 1); unknown screwdriver (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for (1) unk - plates: trauma.This report is 3 of 3 for (b)(4).
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Search Alerts/Recalls
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