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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC. JAWS NITINOL STAPLE SYSTEM
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PARAGON 28, INC. JAWS NITINOL STAPLE SYSTEM Back to Search Results
Model Number P71-018-1818-S
Device Problem Fracture (1260)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
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 the patient underwent a surgical procedure that utilized paragon 28 jaws nitinol staple system.The 18 x 18 mm jaws staple was reported fractured post-operatively.The original surgery date was (b)(6) 2020.A revision surgery has not been scheduled at this time.
 
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Brand Name
JAWS NITINOL STAPLE SYSTEM
Type of Device
STAPLE
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 Key11034287
MDR Text Key225117761
Report Number3008650117-2020-00259
Device Sequence Number1
Product Code JDR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170923
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 12/17/2020
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 NumberP71-018-1818-S
Device Catalogue NumberP71-018-1818-S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/07/2020
Initial Date FDA Received12/18/2020
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 Sequence Number1
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