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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-R1-5550
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544)
Event Date 03/11/2019
Event Type  Injury  
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 a patient underwent a surgical procedure on (b)(6) 2018 that utilized paragon 28 phantom intramedullary nail system. The lapidus nail was used with an allograft and the nail was reported to have broken post-operatively. At 8 weeks, the patient could weight bear however, upon weightbearing, the patient experienced pain. At about 3 months post-operatively, the nail was found broken (week of (b)(6) 2019). The allograft used was not a paragon 28 product and it was reported as a gamma irradiated. It was reported that the graft shattered when the nail was compressed. A revision surgery was performed on (b)(6) 2019 to remove the hardware and the allograft.
 
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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 Key10827279
MDR Text Key215910602
Report Number3008650117-2020-00129
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 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberP30-R1-5550
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 Received03/19/2019
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

Patient Treatment Data
Date Received: 11/12/2020 Patient Sequence Number: 1
Treatment
P24-020-012S 2.0 X 12MMSCREW; P30-110-5517 LAPIDUS NAIL; P30-196-2323 LAPIDUS NAIL, GUIDE PIN & DRILL; P30-196-2720 LAPIDUS NAIL, GUIDE PIN & DRILL; P30-196-2720 LAPIDUS NAIL, GUIDE PIN & DRILL; P30-P1-3516 THREADED PEG, 3.5 X 16MM; P30-P1-3518 THREADED PEG, 3.5 X 18MM; P30-P1-3524 THREADED PEG, 3.5 X 24MM; P30-P1-3528 THREADED PEG, 3.5 X 28MM; P30-S1-3514ANTI-ROTATION PEG, 3.5 X 14MM
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