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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC PHANTOM HINDFOOT TTC/TC NAIL SYSTEM

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PARAGON 28, INC PHANTOM HINDFOOT TTC/TC NAIL SYSTEM Back to Search Results
Model Number P31-315-250L-S
Device Problem Unintended Movement (3026)
Patient Problem Failure of Implant (1924)
Event Date 10/12/2021
Event Type  malfunction  
Manufacturer Narrative
The nail only part number is p31-315-250l with lot number pa2019004627.
 
Event Description
The ttc nail was found to be broken however the surgeon decided to monitor the situation instead of an immediate revision.
 
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Brand NamePHANTOM HINDFOOT TTC/TC NAIL SYSTEM
Type of DevicePHANTOM HINDFOOT TTC/TC NAIL SYSTEM
Manufacturer (Section D)
PARAGON 28, INC
14445 grasslands dr
englewood CO 80112
MDR Report Key12790170
MDR Text Key282492328
Report Number3008650117-2021-00128
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201227
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP31-315-250L-S
Device Catalogue NumberP31-315-250L-S
Device Lot Number5005107
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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