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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC. BABY GORILLA/GORILLA PLATING SYSTEM; REAMER
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PARAGON 28, INC. BABY GORILLA/GORILLA PLATING SYSTEM; REAMER Back to Search Results
Model Number P51-923-0001
Device Problem Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 04/15/2019
Event Type  malfunction  
Manufacturer Narrative
The device history record was reviewed and met all material specifications with no deviation identified.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 nc joint arthrodesis surgical procedure on (b)(6) 2019 that utilized paragon 28 baby gorilla/gorilla plating system.It was reported that the right template appeared chewed up and was creating metal chards.This is report 2 of 2 for this incident.
 
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Brand Name
BABY GORILLA/GORILLA PLATING SYSTEM
Type of Device
REAMER
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 Key10893421
MDR Text Key218678804
Report Number3008650117-2020-00192
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190365
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 11/23/2020
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 NumberP51-923-0001
Device Catalogue NumberP51-923-0001
Device Lot NumberHN114774
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/15/2019
Initial Date FDA Received11/24/2020
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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