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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; DRIVER
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PARAGON 28, INC. SMALL BONE PHANTOM INTRAMEDULLARY NAIL SYSTEM; DRIVER Back to Search Results
Model Number P99-191-LT10
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2019
Event Type  malfunction  
Manufacturer Narrative
Case information including related patient information was not provided by the initial reporter.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 intramedullary nail system on (b)(6) 2019.The surgeon reported 3 lapidus nail drivers as defective.This is report 3 of 3 for this incident.
 
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Brand Name
SMALL BONE PHANTOM INTRAMEDULLARY NAIL SYSTEM
Type of Device
DRIVER
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 Key10873290
MDR Text Key219378484
Report Number3008650117-2020-00178
Device Sequence Number1
Product Code HXX
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 11/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberP99-191-LT10
Device Catalogue NumberP99-191-LT10
Device Lot NumberUPI6588
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2019
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2019
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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