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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OPTIMIZED ORTHO PTY LTD OPTIMIZED POSITIONING SYSTEM; FEMORAL GUIDE
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OPTIMIZED ORTHO PTY LTD OPTIMIZED POSITIONING SYSTEM; FEMORAL GUIDE Back to Search Results
Lot Number MAN_SM_23007
Device Problems Fitting Problem (2183); No Apparent Adverse Event (3189)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/12/2020
Event Type  malfunction  
Manufacturer Narrative
We will provide a follow up report upon completion of our investigation.
 
Event Description
It was reported by a corin representative that the femoral guide had a poor fit.The surgeon proceeded with the use of the guide and made adjustments to compensate for poor fit.There were no adverse patient consequences reported.
 
Event Description
It was reported by a corin representative that the femoral guide had a poor fit.The surgeon proceeded with the use of the guide and made adjustments to compensate for poor fit.There were no adverse patient consequences reported.
 
Manufacturer Narrative
Method: no complaint devices were returned to optimized ortho by the customer.Thus, the device history files were investigated which included reviewing the ops insight plan, ops femoral guide design, pre-operative imaging and all production steps of the femoral guide.Results: the femoral guide was designed correctly as per all ops production processes.No issues were encountered during inspection of the femoral guide.The issue with the guide fitting poorly in surgery may been caused from the segmentation problems.During guide design, the inner surface of the guide is cut using a drape that is generated from the segmentation performed in scanip.A lack of accuracy in segmentation of the patient's bone would result in a poor fitting guide, which would in turn affect the positioning of the resection.Conclusion: the femoral guide for this case was generated correctly and was within all specifications as described in internal procedures.It was found that the likely root cause of this customer complaint was most likely be due to segmentation issues.There were no reported patient consequences for this complaint.
 
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Brand Name
OPTIMIZED POSITIONING SYSTEM
Type of Device
FEMORAL GUIDE
Manufacturer (Section D)
OPTIMIZED ORTHO PTY LTD
17 bridge street
pymble, nsw 2073
AS  2073
MDR Report Key10275155
MDR Text Key204766288
Report Number3012916784-2020-00064
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
PMA/PMN Number
K181061
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 09/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberMAN_SM_23007
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/15/2020
Initial Date FDA Received07/15/2020
Supplement Dates Manufacturer Received06/15/2020
Supplement Dates FDA Received09/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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