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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 04/27/2021
Event Type  malfunction  
Manufacturer Narrative
We are currently in the process of retrieving further information to perform investigation. We will provide a follow up report upon completion. This report is filed with the fda due to an event experienced with a device that is same/similar to those placed on the market in the usa, however, this event occurred outside of the usa. Please note: the submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
 
Event Description
)(: patient was revised due to infection.
 
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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 Key12472233
MDR Text Key271485382
Report Number3012916784-2021-00106
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 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberOPSINSIGHT
Device Lot NumberGAR_RS_28107
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2021
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: 09/15/2021 Patient Sequence Number: 1
Treatment
OPS ACETABULAR GUIDE; OPS FEMORAL GUIDE
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