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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 PHANTOM TTC NAIL, 11.5 X 200MM, RIGHT

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PARAGON 28, INC PHANTOM HINDFOOT TTC/TC NAIL SYSTEM PHANTOM TTC NAIL, 11.5 X 200MM, RIGHT Back to Search Results
Model Number P31-315-200R-S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Discomfort (2330)
Event Date 12/29/2021
Event Type  Injury  
Event Description
Nail fused properly. Surgeon wanted to remove the nail as it was "bothering" the patient at the incision site. Surgical plan was to remove the nail with no replacement as the site was fused properly.
 
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Brand NamePHANTOM HINDFOOT TTC/TC NAIL SYSTEM
Type of DevicePHANTOM TTC NAIL, 11.5 X 200MM, RIGHT
Manufacturer (Section D)
PARAGON 28, INC
14445 grasslands dr
englewood CO 80112
Manufacturer Contact
jenny conger
14445 grasslands dr
englewood, CO 80112
7203721212
MDR Report Key13359736
MDR Text Key284918880
Report Number3008650117-2022-00007
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,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberP31-315-200R-S
Device Catalogue NumberP31-315-200R-S
Device Lot Number5006450
Was Device Available for Evaluation? No
Date Manufacturer Received12/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/26/2022 Patient Sequence Number: 1
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