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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; INSERT, 3D EX SZ 6LT 9MM

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; INSERT, 3D EX SZ 6LT 9MM Back to Search Results
Catalog Number 391-09-706
Device Problems Naturally Worn (2988); 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 poly wear.
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Type of Device
MDR Report Key10806487
MDR Text Key215263142
Report Number1644408-2016-00953
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 11/05/2020
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 No Information
Device Catalogue Number391-09-706
Device Lot Number235732
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;