MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; MALE-FEMALE MIDSECTION, 140

Model Number	25001140E
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: ELEOS
• Common Device Name: MALE-FEMALE MIDSECTION, 140
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 12439290
• Report Number: 3013450937-2021-00184
• Device Sequence Number: 4853080
• Product Code: KRO
• UDI-Device Identifier: B27825001140E0
• UDI-Public: B27825001140E0
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 25001140E
• Device Catalogue Number: 25001140E
• Device Lot Number: 1880175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CUSTOM END CAP IMPLANT (MICROPORT); CUSTOM END CAP IMPLANT (MICROPORT)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR