• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC. PHANTOM SMALL BONE INTRAMEDULLARY NAIL SYSTEM ORTHOPEDIC NAIL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PARAGON 28, INC. PHANTOM SMALL BONE INTRAMEDULLARY NAIL SYSTEM ORTHOPEDIC NAIL Back to Search Results
Model Number P30-R2-5548
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Type  malfunction  
Manufacturer Narrative
Identifying information, such as the lot number of the device was not reported to paragon 28. From returned images of the failure, there was a user deviation from the recommendations in the surgical technique guide. 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 on (b)(6) 2019 that utilized paragon 28 phantom intramedullary nail system. The 3-hole phantom nail was reported broken post-operatively in the cuneiform area. It was said that the surgeon applied good compression over the nail before applying the final screw however, the surgeon did not use the torque indicating driver. The patient was allowed to weight bear in a boot at 3 weeks. When the surgeon saw the patient at 6 weeks, he noticed loss of compression and put the patient on a bone stim. It was reported that the patient went swimming while on vacation and at around 8 weeks post-operatively, the nail appeared broken on xray. The patient experienced mild/moderate pain.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10880954
MDR Text Key219376565
Report Number3008650117-2020-00185
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 11/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP30-R2-5548
Device Catalogue NumberP30-R2-5548
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2019
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

-
-