MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS MALE-FEMALE MIDSECTION 70MM; PROSTHESIS, MIDSECTION

Model Number	25001070E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is for one of five devices involved in the event, please refer to report 3013450937-2018-00013, 3013450937-2018-00014, 3013450937-2018-00015, and 3013450937-2018-00016 for the others.The device history records and sterilization batch release records were reviewed and indicated that all components involved met specification.The operation notes and patient x-rays were requested.It was relayed by the sales representative that the explanted components had been disposed of at the hospital.Should additional information be obtained the report will be supplemented.
Event or Problem Description
Patient underwent a revision surgery due to an alleged infection.
Additional Manufacturer Narrative
This report is for one of five devices involved in the event, please refer to report 3013450937-2018-00013, 3013450937-2018-00014, 3013450937-2018-00015, and 3013450937-2018-00016 for the others.The device history records and sterilization batch release records were reviewed and indicated that all components involved met specification.The operation notes and patient x-rays were requested.It was relayed by the sales representative that the explanted components had been disposed of at the hospital.Should additional information be obtained the report will be supplemented.The root cause of the patient's infection could not be determined, but based upon the operation notes, device history records, sterilization records, and complaint history the investigation concluded that the root cause of the patient's infection was not related to a design, manufacturing, and or sterilization non-conformance and the complaint has been closed.In the event that additional information is provided the complaint will be re-opened and this report will be supplemented.
Event or Problem Description
Patient underwent a revision surgery due to an alleged infection.

• Brand Name: ELEOS MALE-FEMALE MIDSECTION 70MM
• Common Device Name: PROSTHESIS, MIDSECTION
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 7742517
• Report Number: 3013450937-2018-00017
• Device Sequence Number: 13794372
• Product Code: KRO
• UDI-Device Identifier: B27825001070E0
• UDI-Public: B27825001070E0
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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 Expiration Date: 03/11/2025
• Device Model Number: 25001070E
• Device Catalogue Number: 25001070E
• Device Lot Number: 1699749
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR