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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OPTIMIZED ORTHO PTY LTD OPTIMIZED POSITIONING SYSTEM

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OPTIMIZED ORTHO PTY LTD OPTIMIZED POSITIONING SYSTEM Back to Search Results
Model Number OPSINSIGHT
Device Problem Use of Device Problem (1670)
Patient Problem Inadequate Osseointegration (2646)
Event Date 12/16/2021
Event Type  malfunction  
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Brand NameOPTIMIZED POSITIONING SYSTEM
Type of DeviceOPTIMIZED POSITIONING SYSTEM
Manufacturer (Section D)
OPTIMIZED ORTHO PTY LTD
17 bridge street
pymble, nsw 2073
AS 2073
Manufacturer (Section G)
OPTIMIZED ORTHO PTY LTD
17 bridge street
pymble, nsw 2073
AS 2073
Manufacturer Contact
james tai
17 bridge street
pymble, nsw 2073
AS   2073
MDR Report Key13297319
Report Number3012916784-2022-00111
Device Sequence Number1
Product Code PBF
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K192656
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberOPSINSIGHT
Device Lot NumberHAR_BP_55209
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/19/2022 Patient Sequence Number: 1
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