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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
Catalog Number P71-020-2020-S
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/22/2018
Event Type  Injury  
Event Description
It was reported that the patient underwent a surgical procedure for revision to a tarsometatarsal fusion and the paragon 28 staple was used to revise.The surgery took place on (b)(6) 2017.During post-operative care, the staple broke and was removed in a revision surgery that took place on (b)(6) 2018.There was a non-union at the site.During evaluation and investigation, the broken staple was evaluated.It was found to be broken across the bridge of the device.There was no other visible damage to the part.The dhr records of implants involved with the case were reviewed.All records indicate the implants were manufactured according to specification.
 
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Brand Name
JAWS NITINOL STAPLE SYSTEM
Type of Device
ORTHOPEDIC BONE STAPLE
Manufacturer (Section D)
PARAGON 28, INC.
4b inverness ct. e
suite 280
englewood CO 80112
Manufacturer Contact
mackenzie belden
4b inverness ct. e.
suite 280
englewood, CO 80112
7206431300
MDR Report Key7710191
MDR Text Key114697742
Report Number3008650117-2018-00009
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 07/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberP71-020-2020-S
Device Lot Number260328917A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/22/2018
Initial Date FDA Received07/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
P20-555-060L, MONSTER SCREW, NOT REMOVED
Patient Outcome(s) Required Intervention;
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