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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
Model Number P30-L1-5548
Device Problem Break (1069)
Patient Problems Pain (1994); Non-union Bone Fracture (2369)
Event Type  malfunction  
Manufacturer Narrative
Identifying information, such as the lot number of the device was not reported to paragon 28 so the dhr could not be reviewed. 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 that utilized a paragon 28 phantom intramedullary nail on (b)(6) 2018. The nail was reported to have broken post-operatively at the distal cuneiform hole. The patient underwent 6 weeks of non-weightbearing and was released by the surgeon 3 months post-operatively. It was reported that the patient went hiking and felt pain. The nail was found broken with a non-union. The patient was put in a boot and given bone stimulation. No revision was reported.
 
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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
mackenzie belden
14445 grasslands dr.
englewood, CO 80112
7206431300
MDR Report Key10806913
MDR Text Key216940752
Report Number3008650117-2020-00091
Device Sequence Number1
Product Code KTW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182307
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 11/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP30-L1-5548
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 Received07/31/2018
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 Unkown

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