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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSERT, 3D EX SZ 7RT 9MM

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INSERT, 3D EX SZ 7RT 9MM Back to Search Results
Catalog Number 392-09-707
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
Corrected data: original initial report was submitted as follow up in error.
 
Event Description
Revision surgery - due to the patient not functioning properly; the surgeon decided to do a poly swap.
 
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Type of DeviceINSERT, 3D EX SZ 7RT 9MM
MDR Report Key10806455
MDR Text Key215251664
Report Number1644408-2016-00870
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 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number392-09-707
Device Lot Number329G1046
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: 11/08/2020 Patient Sequence Number: 1
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