Model Number DWD-232 |
Device Problems
Device Contamination With Biological Material (2908); Patient Device Interaction Problem (4001)
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Patient Problem
Bacterial Infection (1735)
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Event Type
Injury
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Manufacturer Narrative
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Reviewed sterilization and sterile barrier inspection records for probable lot.No pattern related to irradiation dose lot or device lot was noted.Confirmed labeling included cautions regarding pin site care.
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Event Description
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Patient had surgery to install the digit widget external fixation system.Physician reported, "patient developed pin tract infection and required early removal of device, is on humira for pa and immunosuppressed." device removed after 8 weeks of treatment.
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Event Description
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Patient had surgery to install the digit widget external fixation system.Physician reported, "patient developed pin tract infection and required early removal of device, is on humira for pa and immunosuppressed." device removed after 8 weeks of treatment.
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Manufacturer Narrative
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Reviewed sterilization and sterile barrier inspection records for probable lot.No pattern related to irradiation dose lot or device lot was noted.Confirmed labeling included cautions regarding pin site care.
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Search Alerts/Recalls
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