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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS TRIAL POLY SPACER

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ONKOS SURGICAL ELEOS TRIAL POLY SPACER Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/26/2021
Event Type  malfunction  
Manufacturer Narrative
The root cause has not been able to be evaluated as no informaiton about the devices has been given by the complainant. If more information is recieved, a supplemental report will be submitted.
 
Event Description
It was reported that a trial tibial poly spacer was damaged while being used intraoperatively. The trial was discarded and a new trial was used. The delay to surgery is unknown at this time. A supplemental report will be submitted when more information is known.
 
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Brand NameELEOS
Type of DeviceTRIAL POLY SPACER
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
Manufacturer (Section G)
MICROPORT ORTHOPEDICS
5677 airline road
arlington TN 38002
Manufacturer Contact
jonathan zachok
77 east halsey road
parsippany, NJ 07054
MDR Report Key12383493
MDR Text Key268699933
Report Number3013450937-2021-00174
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161520
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/30/2021 Patient Sequence Number: 1
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