Model Number 25001140E |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Pain (1994)
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Event Date 08/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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The root cause for the segment being too long was unable to be definitively determined.However, there was no report that the eleos implant involved contributed to the complaint.Further, there was no indication that there was an issue during manufacturing or sterilization of the implant; therefore, the eleos components most likely did not contribute to this complaint.
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Event Description
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A patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6).The surgery was performed due to the segment being too long after surgery and shortening was required.There was no report that the eleos component failed or contributed to the revision.During the surgery, the surgeon removed a 140mm male-female midsection and a custom end cap implant manufactured by microport and placed a 90mm male-female midsection.He then replaced the custom end cap.It is unknown what caused the segment to be too long for the patient.
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Event Description
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A patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6).The surgery was performed due to the segment being too long after surgery and shortening was required.There was no report that the eleos component failed or contributed to the revision.During the surgery, the surgeon removed a 140mm male-female midsection and a custom end cap implant manufactured by microport and placed a 90mm male-female midsection.He then replaced the custom end cap.It is unknown what caused the segment to be too long for the patient.
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Manufacturer Narrative
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The implant reported in this mdr was implanted on (b)(6) 2021 and explanted and revised on (b)(6) 2021.The initial dates reported were incorrect.
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Search Alerts/Recalls
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