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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CANAL-FILLING SEGMENTAL STEM, 14X120MM STRAIGHT SPLINED FULL PLASMA 32MM COLLAR
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ONKOS SURGICAL ELEOS; CANAL-FILLING SEGMENTAL STEM, 14X120MM STRAIGHT SPLINED FULL PLASMA 32MM COLLAR Back to Search Results
Model Number FS-14120-03M
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Insufficient Information (4580)
Event Date 10/14/2022
Event Type  malfunction  
Event Description
It was reported that the patient's canal-filling segmental stem loosened in their right distal femur and it will require surgical intervention.A revision surgery is anticipated but has not yet been scheduled.No additional information regarding this event has been provided.
 
Manufacturer Narrative
The investigation is in process.A revision surgery is anticipated but has not yet been scheduled.When the investigation is complete, a supplemental mdr will be submitted accordingly.
 
Event Description
It was reported that the patient's canal-filling segmental stem loosened in their right distal femur and it will require surgical intervention.A revision surgery is anticipated but has not yet been scheduled.No additional information regarding this event has been provided.
 
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.
 
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Brand Name
ELEOS
Type of Device
CANAL-FILLING SEGMENTAL STEM, 14X120MM STRAIGHT SPLINED FULL PLASMA 32MM COLLAR
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
Manufacturer (Section G)
PHILLIPS PRECISION INC
7 paul kohner pl
elmwood park NJ 07407
Manufacturer Contact
sara dailey
77 east halsey road
parsippany, NJ 07054
MDR Report Key15784192
MDR Text Key304882426
Report Number3013450937-2022-00333
Device Sequence Number1
Product Code KRO
UDI-Device IdentifierB278FS1412003M0
UDI-PublicB278FS1412003M0
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 02/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/18/2024
Device Model NumberFS-14120-03M
Device Catalogue NumberFS-14120-03M
Device Lot Number81694
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
P/N 25000009E, ELEOS DISTAL FEMUR; P/N 25001040E, ELEOS MALE FEMALE MIDSECTION; P/N 25001040E, ELEOS MALE FEMALE MIDSECTION; P/N 25001208E, ELEOS POLY SPACER; P/N 25002100E, ELEOS TIBIAL HINGE COMPONENT; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N 25002203E, ELEOS TIBIAL BASEPLATE; P/N KSP11100E, ELEOS STEM EXTENSION
Patient Age32 YR
Patient SexMale
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