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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC PHANTOM HINDFOOT TTC/TC SYSTEM

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PARAGON 28, INC PHANTOM HINDFOOT TTC/TC SYSTEM Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369)
Event Date 09/15/2021
Event Type  Injury  
Event Description
Patient reported to have post-op infection and non-union; no alleged product deficiency. A revision surgery was conducted on (b)(6) 2021, however, the implant was not explanted.
 
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Type of DevicePHANTOM HINDFOOT TTC/TC SYSTEM
Manufacturer (Section D)
PARAGON 28, INC
14445 grasslands dr
englewood CO 80112
Manufacturer Contact
jenny conger
14445 grasslands dr
englewood, CO 80112
MDR Report Key12582742
MDR Text Key274926214
Report Number3008650117-2021-00116
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
Type of Report Initial
Report Date 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received09/15/2021
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: 10/06/2021 Patient Sequence Number: 1
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