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

Model Number 25001140E

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 08/12/2021

Event Type  Injury  

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 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 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.

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
• Type of Device: MALE-FEMALE MIDSECTION, 140
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 12439290
• MDR Text Key: 273687750
• Report Number: 3013450937-2021-00184
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825001140E0
• UDI-Public: B27825001140E0
• Combination Product (y/n): N
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25001140E
• Device Catalogue Number: 25001140E
• Device Lot Number: 1880175
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUSTOM END CAP IMPLANT (MICROPORT); CUSTOM END CAP IMPLANT (MICROPORT)
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR