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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC. JAWS NITINOL STAPLE SYSTEM; ORTHOPEDIC BONE STAPLE
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PARAGON 28, INC. JAWS NITINOL STAPLE SYSTEM; ORTHOPEDIC BONE STAPLE Back to Search Results
Model Number P71-015-1515-S
Device Problems Output above Specifications (1432); Difficult to Remove (1528)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  malfunction  
Manufacturer Narrative
During evaluation and investigation, the implants were not available for analysis.The device manufacturing and inspection records were analyzed for the device.No deviations were noted.If any further information is found which would change or alter any conclusions or information,a supplemental report will be filed accordingly.
 
Event Description
Physician reported having experience difficulty removing staple inserter while utilizing paragon 28 jaws staple system.The physician alleges that the staples get much compression and tear through patient's bone.
 
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Brand Name
JAWS NITINOL STAPLE SYSTEM
Type of Device
ORTHOPEDIC BONE 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 Key10782977
MDR Text Key226578105
Report Number3008650117-2020-00078
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 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberP71-015-1515-S
Device Catalogue NumberP71-015-1515-S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/02/2018
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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