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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 EXPLANT ATTACHMENT, PHANTOM HINDFOOT

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PARAGON 28, INC PHANTOM HINDFOOT TTC/TC NAIL SYSTEM EXPLANT ATTACHMENT, PHANTOM HINDFOOT Back to Search Results
Model Number P31-958-0001
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2022
Event Type  malfunction  
Event Description
The surgeon had difficulty during a surgery connecting the removal instrument to the implant which contained bony ingrowth. Item 1 of 2.
 
Manufacturer Narrative
Limited information.
 
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Brand NamePHANTOM HINDFOOT TTC/TC NAIL SYSTEM
Type of DeviceEXPLANT ATTACHMENT, PHANTOM HINDFOOT
Manufacturer (Section D)
PARAGON 28, INC
14445 grasslands dr
englewood CO 80112
Manufacturer Contact
jenny conger
14445 grasslands dr
englewood, CO 80112
7203751212
MDR Report Key14174335
MDR Text Key291318207
Report Number3008650117-2022-00042
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP31-958-0001
Device Catalogue NumberP31-958-0001
Was Device Available for Evaluation? No
Date Manufacturer Received03/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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