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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSERT, 3D EX SZ 10LT 9MM

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INSERT, 3D EX SZ 10LT 9MM Back to Search Results
Catalog Number 391-09-710
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Corrected data: original initial report was submitted as follow up in error.
 
Event Description
Revision surgery - due to looseness; the surgeon put in different size poly.
 
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Type of DeviceINSERT, 3D EX SZ 10LT 9MM
MDR Report Key10635954
MDR Text Key210179629
Report Number1644408-2016-00402
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 10/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number391-09-710
Device Lot Number59605131
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: 10/06/2020 Patient Sequence Number: 1
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