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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSERT, 3D EX SZ 4LT 11MM

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INSERT, 3D EX SZ 4LT 11MM Back to Search Results
Catalog Number 391-11-704
Device Problems Unstable (1667); Appropriate Term/Code Not Available (3191)
Patient Problem Failure of Implant (1924)
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 becoming unstable.
 
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Type of DeviceINSERT, 3D EX SZ 4LT 11MM
MDR Report Key11811774
MDR Text Key250181944
Report Number1644408-2016-00802
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 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number391-11-704
Device Lot Number59603997
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: 05/12/2021 Patient Sequence Number: 1
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