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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 21; HEART-VALVE, MECHANICAL
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ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 21; HEART-VALVE, MECHANICAL Back to Search Results
Model Number ONXACE-21
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 04/04/2022
Type of Reportable Event Serious Injury
Event or Problem Description
According to the initial report received, "another aortic implant found for same patient.New implant sn (b)(4) onxace 23".
 
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Brand Name
ONX AORTIC CONFORM EXT 21
Common Device Name
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
ON-X LIFE TECHNOLOGIES, INC.
1300 e. anderson ln., bldg. b
austin TX 78752
Manufacturer (Section G)
ON-X LIFE TECHNOLOGIES, INC.
1300 e. anderson ln., bldg. b
austin TX 78752
Manufacturer Contact
rochelle maney
1655 roberts blvd. nw
kennesaw, GA 30144
7704193355
MDR Report Key14745069
Report Number1649833-2022-00034
Device Sequence Number12094113
Product Code LWQ
UDI-Device Identifier00851788001457
UDI-Public851788001457
Combination Product (Y/N)N
Initial Reporter StateIA
Initial Reporter CountryUS
PMA/510(K) Number
P000037
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Company Representative
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 08/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Expiration Date02/09/2024
Device Model NumberONXACE-21
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/02/2022
Supplement Date Received by Manufacturer06/02/2022
Initial Report FDA Received Date06/20/2022
Supplement Report FDA Received Date08/05/2022
Is the Device Labeled for Single Use? (Y/N) Yes
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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