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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC PHANTOM ACTIVCORE NAIL PHANTOM ACTIVCORE NAIL, 11.5 X 300MM

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PARAGON 28, INC PHANTOM ACTIVCORE NAIL PHANTOM ACTIVCORE NAIL, 11.5 X 300MM Back to Search Results
Model Number P31-115-3000-S
Device Problems Difficult to Remove (1528); Activation Problem (4042)
Patient Problem Unspecified Infection (1930)
Event Date 03/15/2021
Event Type  Injury  
Manufacturer Narrative
Dhr inspection signed 8/19/2020 and noted to be within specifications. All pieces were accepted with no ncr's noted. If any additional information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
 
Event Description
Paragon 28 phantom nail was implanted (b)(6) 2020. Patient developed an infection and surgeon attempted to revise implant on (b)(6) 2021. It was reported the surgeon typically does not use an end cap, the threads of the nail are thin and fine, and they could not get the "bolts" to engage the nail. Surgeon was not able to remove the implant. Patient was prescribed antibiotics and referred to a bigger hospital downtown (b)(6) for removal.
 
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Brand NamePHANTOM ACTIVCORE NAIL
Type of DevicePHANTOM ACTIVCORE NAIL, 11.5 X 300MM
Manufacturer (Section D)
PARAGON 28, INC
14445 grasslands dr
englewood CO 80112
Manufacturer Contact
jenny conger
14445 grasslands dr
englewood, CO 80112
4406106899
MDR Report Key11661123
MDR Text Key245962452
Report Number3008650117-2021-00082
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 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberP31-115-3000-S
Device Catalogue NumberP31-115-3000-S
Device Lot Number5005811
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 Received03/15/2021
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: 04/13/2021 Patient Sequence Number: 1
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