Device Problem
Difficult to Advance (2920)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This report is for an unknown- screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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 (b)(6) reports an event as follows: it was reported on (b)(6) 2020 that the patient underwent a surgery for transpedicular fixation of lumbar spine due to fracture.During the surgery, the tightener was failed to tighten the expedium screws.The surgery was successfully completed with no delay reported.The patient outcome was unknown.Concomitant device reported: unknown screws (part#: unknown, lot#: unknown, quantity: unknown ).This complaint involves six (6) devices.This report is for (1) unknown screws.This is report 4 of 4 for (b)(4).
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Manufacturer Narrative
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Updated additional event information 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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There were no fragment generated and patient do not need any additional intervention.Patient no need any revision surgery.
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Event Description
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There were no fragment generated and patient do not need any additional intervention.Patient no need any revision surgery.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: b5: updated additional event information h6: codes updated 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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Search Alerts/Recalls
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