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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL BASEPLATE
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ONKOS SURGICAL ELEOS; TIBIAL BASEPLATE Back to Search Results
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
The investigation is in progress.When it is complete a supplemental mdr will be submitted accordingly.
 
Event Description
It was reported that the patient has an alleged loose proximal tibia baseplate based off review of the patient's xrays.The patient is going to get a second opinion.No revision surgeries have been rescheduled.Attempts have been made and no other information has been made available.
 
Manufacturer Narrative
The investigation is in progress.When it is complete a supplemental mdr will be submitted accordingly.
 
Event Description
It was reported that the patient has an alleged loose proximal tibia baseplate based off review of the patient's xrays.The patient is going to get a second opinion.No revision surgeries have been rescheduled.Attempts have been made and no other information has been made available.
 
Manufacturer Narrative
This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The root cause of the alleged implant loosening could not be determined.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: b4: date of this report added.G3: date received by manufacturer added.G6: type of report added.H2: follow-up type added.H3: device evaluated by manufacturer updated to no.H6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 4117: device not accessible for testing.H6: investigation findings code updated to 3221: no findings available.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.
 
Event Description
It was reported that the patient has an alleged loose proximal tibia baseplate based off review of the patient's xrays.The patient is going to get a second opinion.No revision surgeries have been rescheduled.Attempts have been made and no other information has been made available.
 
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Brand Name
ELEOS
Type of Device
TIBIAL BASEPLATE
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
Manufacturer Contact
danielle pierce
77 east halsey road
parsippany, NJ 07054
8447672766
MDR Report Key13193485
MDR Text Key285503245
Report Number3013450937-2022-00003
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 Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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