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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL CONFORM 25/33; HEART-VALVE, MECHANICAL

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ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL CONFORM 25/33; HEART-VALVE, MECHANICAL Back to Search Results
Model Number ONXMC-25/33
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Endocarditis (1834); Insufficient Information (4580)
Event Date 03/27/2022
Event Type  Injury  
Event Description
According to the initial report, onxmc-25/33 serial number (sn) (b)(4) was implanted on (b)(6) 2022 and explanted on (b)(6) 2022.Cause of explant is still currently unknown.
 
Event Description
According to the initial report, onxmc-25/33 serial number (sn) (b)(6) was implanted on (b)(6), 2022 and explanted on (b)(6) 2022.
 
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Brand Name
ONX MITRAL CONFORM 25/33
Type of Device
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 Key14742883
MDR Text Key295040082
Report Number1649833-2022-00029
Device Sequence Number1
Product Code LWQ
UDI-Device Identifier00851788001303
UDI-Public851788001303
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/18/2022
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
Device Model NumberONXMC-25/33
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date05/19/2022
Initial Date Manufacturer Received 05/19/2022
Initial Date FDA Received06/20/2022
Supplement Dates Manufacturer Received05/19/2022
Supplement Dates FDA Received08/18/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age39 YR
Patient SexMale
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