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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 HINDFOOT REAMER, 13.0MM
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PARAGON 28, INC. PHANTOM HINDFOOT TTC/TC NAIL SYSTEM; PHANTOM HINDFOOT REAMER, 13.0MM Back to Search Results
Model Number P31-955-0130
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2022
Event Type  malfunction  
Manufacturer Narrative
This is report 1 of 2 for this incident.
 
Event Description
Two mating parts were stuck together which caused significant delay in surgery.
 
Event Description
Based on additional information and product evaluation, there was mating interaction failure between the reamer head and reamer shaft which was as a result of user error.
 
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Brand Name
PHANTOM HINDFOOT TTC/TC NAIL SYSTEM
Type of Device
PHANTOM HINDFOOT REAMER, 13.0MM
Manufacturer (Section D)
PARAGON 28, INC.
14445 grasslands dr.
englewood CO 80112
Manufacturer Contact
victoria akinboboye
14445 grasslands dr.
englewood, CO 80112
7207165439
MDR Report Key14247841
MDR Text Key295149021
Report Number3008650117-2022-00047
Device Sequence Number1
Product Code HTO
Combination Product (y/n)N
Reporter Country CodeSF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberP31-955-0130
Device Catalogue NumberP31-955-0130
Device Lot NumberPE139223
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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