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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 ACTIVCORE NAIL

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PARAGON 28, INC. PHANTOM HINDFOOT TTC/TC NAIL SYSTEM PHANTOM ACTIVCORE NAIL Back to Search Results
Model Number P31-102-1750-S
Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 12/29/2020
Event Type  Injury  
Manufacturer Narrative
Devices are not expected to be returned for the manufacturer review/investigation; the patient requested to keep the explanted hardware. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
 
Event Description
It was reported that the patient underwent a surgical procedure on (b)(6) 2020 that utilized paragon 28 phantom hindfoot ttc/tc nail system. The procedure went well, and the post-operative images was reported to have been great. On (b)(6) 2020, a revision surgery was performed to remove the phantom activcore nail from the patient due to fractured implant. It was reported that the patient was not compliant with the post-operative care instructions and ambulated early. The fracture was displaced and caused the proximal portion of the nail to flex beyond its tolerance which led to the breakage.
 
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Brand NamePHANTOM HINDFOOT TTC/TC NAIL SYSTEM
Type of DevicePHANTOM ACTIVCORE NAIL
Manufacturer (Section D)
PARAGON 28, INC.
14445 grasslands dr.
englewood CO 80112
Manufacturer Contact
victoria akinboboye
14445 grasslands dr.
englewood, CO 80112
7206431300
MDR Report Key11121718
MDR Text Key225274057
Report Number3008650117-2021-00001
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 01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberP31-102-1750-S
Device Catalogue NumberP31-102-1750-S
Device Lot Number5005804
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/24/2020
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: 01/05/2021 Patient Sequence Number: 1
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