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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

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PARAGON 28, INC PHANTOM HINDFOOT TTC/TC NAIL SYSTEM PHANTOM TTC NAIL Back to Search Results
Model Number P31-315-200L-S
Device Problem Unintended Movement (3026)
Patient Problem Limb Fracture (4518)
Event Date 10/09/2021
Event Type  Injury  
Manufacturer Narrative
Captured the kit level information. The nail only part number is p31-315-200l with lot number pa2019004625.
 
Event Description
The ttc nail was found to be broken however the surgeon decided to monitor the situation instead of an immediate revision. It was reported the patient was overweight, non-compliant, and fell in the shower 4 days later. Patient suffered a serious injury and revision surgery was completed the same day.
 
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Brand NamePHANTOM HINDFOOT TTC/TC NAIL SYSTEM
Type of DevicePHANTOM TTC NAIL
Manufacturer (Section D)
PARAGON 28, INC
14445 grasslands dr
englewood CO 80112
MDR Report Key12738168
MDR Text Key279590329
Report Number3008650117-2021-00126
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K201227
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP31-315-200L-S
Device Catalogue NumberP31-315-200L-S
Device Lot Number5005105
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2020
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: 11/02/2021 Patient Sequence Number: 1
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