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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC. SMALL BONE PHANTOM INTRAMEDULLARY NAIL SYSTEM; ORTHOPEDIC NAIL
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PARAGON 28, INC. SMALL BONE PHANTOM INTRAMEDULLARY NAIL SYSTEM; ORTHOPEDIC NAIL Back to Search Results
Model Number P30-900-100R
Device Problem Failure to Power Up (1476)
Patient Problem Insufficient Information (4580)
Event Date 03/29/2019
Event Type  malfunction  
Manufacturer Narrative
The device history record was reviewed and met all material specifications with no deviation identified.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 paragon 28 phantom screw system.It was reported that the compression screw would not turn on the outrigger.
 
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Brand Name
SMALL BONE PHANTOM INTRAMEDULLARY NAIL SYSTEM
Type of Device
ORTHOPEDIC 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 Key10872138
MDR Text Key219377749
Report Number3008650117-2020-00171
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 Physician
Type of Report Initial
Report Date 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberP30-900-100R
Device Catalogue NumberP30-900-100R
Device Lot NumberTN54810
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/29/2019
Initial Date FDA Received11/19/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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