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Device Problem
Migration (4003)
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Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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Event Description
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Device report from the netherlands reports an event as follows: the site roe (rotterdam, netherlands) reported an adverse event in the ao database which is considered (possibly) related to the device.Subject roe-050.Ae1: postoperative adverse event: "other ae related to the procedure or implant ¿ rotational deviation (45 degrees) of the tibia." is the ae related to the tibial fracture and/or treatment of tibial fracture? "yes." is the ae related to the device? "possible." dps implant was used.Patient was treated with external fixation on (b)(6) 2023 for open fracture of the left tibia and fibula.Tibial nail was implanted on (b)(6) 2023.Revision surgery occurred on (b)(6), 2023, to de-rotate the tibia.This report is for an unknown locking screw.This is report 4 of 4 for (b)(4).
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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a1: patient born on an unknown date in 1972.D1, d2, d3, d4, g4 - 510k: this report is for an unknown screw/unknown lot.Part and lot number are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: incident occurred in the netherlands, however, initial reporter is located in switzerland.H3, h4, h6: 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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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.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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Additional adverse event reported: postoperative adverse event: "nonunion".Is the ae related to the tibial fracture and/or treatment of tibial fracture? "yes".Is the ae related to the device? "possible".Dps implant was used.
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Event Description
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This complaint was reviewed, and it was determined that the nonuinon reported was a separate event, which was captured in (b)(4).This report captures the first adverse event of physical asymmetry: ae1: postoperative adverse event: "other ae related to the procedure or implant ¿ rotational deviation (45 degrees) of the tibia".Is the ae related to the tibial fracture and/or treatment of tibial fracture? "yes".Is the ae related to the device? "possible".Dps implant was used.Patient was treated with external fixation on (b)(6), 2023 for open fracture of the left tibia and fibula.Tibial nail was implanted on (b)(6), 2023.Revision surgery occurred on (b)(6), 2023, to de-rotate the tibia.
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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.Corrected data: b5: event description updated.H6: health effect codes and medical device problem 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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