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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; OUTRIGGER ASSEMBLY
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PARAGON 28, INC. PHANTOM SMALL BONE INTRAMEDULLARY NAIL SYSTEM; OUTRIGGER ASSEMBLY Back to Search Results
Model Number P30-900-100L
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Insufficient Information (4580)
Event Date 03/04/2020
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 intramedullary nail system on (b)(6) 2020.The lapidus nail outrigger assembly was said to have stripped intra-operatively, as the torque driver was inserted into the compression slot in order to decompress before inserting the nail.
 
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Brand Name
PHANTOM SMALL BONE INTRAMEDULLARY NAIL SYSTEM
Type of Device
OUTRIGGER ASSEMBLY
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 Key10964106
MDR Text Key220727750
Report Number3008650117-2020-00226
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 Other
Type of Report Initial
Report Date 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberP30-900-100L
Device Catalogue NumberP30-900-100L
Device Lot NumberTN55499
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2020
Date Manufacturer Received03/04/2020
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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