MAUDE Adverse Event Report: ONKOS SURGICAL INC. ELEOS; UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/05/2022

Event Type  Injury  

Event Description

It was reported that a patient had a distal femoral replacement revision surgery scheduled for (b)(6) 2022.This surgery was cancelled.It is unknown what complications the patient is experiencing.Attempts have been made and no further information has been provided.

Manufacturer Narrative

The investigation is in process.Multiple attempts have been made to obtain more information regarding this event.If additional information is received, a supplemental report will be submitted accordingly.When the investigation is complete, a supplemental report will be filed accordingly.

Manufacturer Narrative

An mdr was submitted for this event on 02 september 2022.Additional information was received on 03 november 2022 which confirmed that this patient does not have any onkos surgical devices implanted, therefore, this report is being cancelled.There was no onkos surgical device involvement in this adverse event.

Event Description

An mdr was submitted for this event on 02 september 2022.Additional information was received on 03 november 2022 which confirmed that this patient does not have any onkos surgical devices implanted, therefore, this report is being cancelled.

• Brand Name: ELEOS
• Type of Device: UNKNOWN
• Manufacturer (Section D): ONKOS SURGICAL INC.; 77 east halsey road; parsippany NJ 07054
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 15351589
• MDR Text Key: 299207300
• Report Number: 3013450937-2022-00256
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization