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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSERT, 3D EX SZ 8LT 13MM

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INSERT, 3D EX SZ 8LT 13MM Back to Search Results
Catalog Number 391-13-708
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Swelling (2091); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative
Corrected data: original initial report was submitted as follow up in error.
 
Event Description
Revision surgery - the patient had a cyst removed. The patient later complained of swelling in the knee and had difficulty walking. The surgeon inspected the knee for infection; the patients knee was opened and thoroughly cleaned which required the poly to be removed. A new poly was then required to be put in its place.
 
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Type of DeviceINSERT, 3D EX SZ 8LT 13MM
MDR Report Key10707533
MDR Text Key212272153
Report Number1644408-2016-00534
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 10/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number391-13-708
Device Lot Number59600995
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/20/2020 Patient Sequence Number: 1
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