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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC. PHANTOM SMALL BONE INTRAMEDULLARY NAIL SYSTEM ORTHOPEDIC NAIL

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PARAGON 28, INC. PHANTOM SMALL BONE INTRAMEDULLARY NAIL SYSTEM ORTHOPEDIC NAIL Back to Search Results
Device Problem Break (1069)
Patient Problem Pain (1994)
Event Type  malfunction  
Manufacturer Narrative
Identifying information of the part, such as the part number and lot number of the device was not reported to paragon 28. Devices are not expected to be returned for the manufacturer review/investigation. 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 lapidus arthrodesis surgical procedure on (b)(6) 2018 that utilized a paragon 28 phantom intramedullary nail. The lapidus nail was reported to have broken at the distal cuneiform hole post-operatively. The patient is said to be doing fine with some pain on the plantar fascia. The patient is using a walker and with partial weight bearing of 10-15 kg for 4 weeks. The radiographic images confirmed the break at the distal cuneiform hole. The nail is not expected to be returned and the physician does not plan on revising.
 
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Brand NamePHANTOM SMALL BONE INTRAMEDULLARY NAIL SYSTEM
Type of DeviceORTHOPEDIC 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 Key10812098
MDR Text Key219377311
Report Number3008650117-2020-00110
Device Sequence Number1
Product Code KTW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K182307
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 11/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received12/18/2018
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

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