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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 OPS PLAN AND DHA
Device Problem Use of Device Problem (1670)
Patient Problem Inadequate Osseointegration (2646)
Event Date 08/09/2021
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.
 
Event Description
(b)(6): revision 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
MDR Report Key12323372
MDR Text Key280703220
Report Number3012916784-2021-00100
Device Sequence Number1
Product Code PBF
Combination Product (y/n)N
PMA/PMN Number
K171847
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberOPS PLAN AND DHA
Device Lot NumberHAM_EJ_13552
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/16/2021 Patient Sequence Number: 1
Treatment
OPS ACETABULAR GUIDE; OPS ACETABULAR GUIDE; OPS FEMORAL GUIDE; OPS FEMORAL GUIDE
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