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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-L1-5540
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  malfunction  
Manufacturer Narrative
Identifying information, such as the lot number of the device was not reported to paragon 28. Case information including related patient information was not provided by the initial reporter. 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 surgical procedure that utilized a paragon 28 phantom nail system on (b)(6) 2018. The lapidus nail was reported broken at the distal cuneiform hole. On (b)(6) 2018, at the 6 months follow-up appointment, patient did not report any issue. The nail was implanted for about 12 months before the nail break, and there was no pain reported by patient, however, there was swelling. It was reported that a bone stimulator and injection was used to combat the swelling. The initial reporter mentioned that the lisfranc area of the patient appears to be sinking. A revision surgery was not 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
victoria akinboboye
14445 grasslands dr.
englewood, CO 80112
7206431300
MDR Report Key10973888
MDR Text Key221294768
Report Number3008650117-2020-00236
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 12/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP30-L1-5540
Device Catalogue NumberP30-L1-5540
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 Received04/17/2019
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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