Catalog Number 04.004.555SAB |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Hematoma (1884); Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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Additional narrative: patient height reported as (b)(6).Patient¿s date of birth is an unknown date in 1979.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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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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The site (b)(6) reported two adverse events in our database which is considered (possibly) related to the device.Subject mue-010.Postoperative adverse event: "soft tissue wound lower leg; the epigard and the dermotraction still secrete bloody." is the ae related to the tibial fracture and/or treatment of tibial fracture? "yes." is the ae related to the device? "yes." dps implant was used.This report is for a 11mm ti cannulated tibial nail-ex/375mm-sterile.This is report 1 of 5 for (b)(4).Additional reports are captured under (b)(4).
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Event Description
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The initial complaint was reviewed and found not reportable.It was determined this report is a duplicate report.Event was captured on complaint (b)(4), medwatch report 8030965-2022-02111.
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Search Alerts/Recalls
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