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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL MY 3D PERSONALIZED SOLUTIONS; PATIENT SPECIFIC DISTAL HUMERAL IMPLANT
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ONKOS SURGICAL MY 3D PERSONALIZED SOLUTIONS; PATIENT SPECIFIC DISTAL HUMERAL IMPLANT Back to Search Results
Model Number C22-331-0001
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Insufficient Information (4580)
Event Date 08/07/2023
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 while implanting a my3d custom distal humeral implant with an eleos biogrip collared stem that the surgeon was unable to complete the reduction and close the patient.The soft tissue was tight so the surgeon opted to fill the void with a spacer.A revision surgery is being planned with a newly designed custom implant.No further 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 reported adverse event 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: type of investigation code updated to 3331: analysis of production records.H6: type of investigation code updated to 4111: communication/interviews.H6: type of investigation code updated to 4109: historical data analysis.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 while implanting a my3d custom distal humeral implant with an eleos biogrip collared stem that the surgeon was unable to complete the reduction and close the patient.The soft tissue was tight so the surgeon opted to fill the void with a spacer.A revision surgery is being planned with a newly designed custom implant.No further information has been made available.
 
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Brand Name
MY 3D PERSONALIZED SOLUTIONS
Type of Device
PATIENT SPECIFIC DISTAL HUMERAL IMPLANT
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
Manufacturer (Section G)
3D SYSTEMS
5381 s alkire st
littleton CO 80127
Manufacturer Contact
danielle pierce
77 east halsey road
parsippany, NJ 07054
MDR Report Key17694674
MDR Text Key322781638
Report Number3013450937-2023-00191
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Reporter Country CodeUS
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 11/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberC22-331-0001
Device Catalogue NumberC22-331-0001
Device Lot NumberC22-331
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/04/2023
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
25001040E ELEOS MALE-FEMALE MIDESECTION 40MM; 25001050E ELEOS MALE-FEMALE MIDSECTION 50MM; HC-11120-03M ELEOS CEMENTED SEGMENTAL STEM; HR-30001-03M ELEOS MODULAR COLLAR LOCKING RING; PB-2800R-03M ELEOSMODULAR POROUS BIOGRIP HA COLLAR
Patient Outcome(s) Hospitalization;
Patient Age16 YR
Patient SexFemale
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