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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC. BABY GORILLA/GORILLA PLATING SYSTEM; OLIVE WIRE
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PARAGON 28, INC. BABY GORILLA/GORILLA PLATING SYSTEM; OLIVE WIRE Back to Search Results
Model Number P99-201-1406
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 11/17/2020
Event Type  malfunction  
Manufacturer Narrative
The provided picture of the olive wire confirms the break.Patient information was not provided by the initiator.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 gorilla screw system.The 1.4mm half threaded olive wire was reported broken during the removal process from patient's body.The surgeon dug out the remains of the olive wire.It was confirmed that the surgeon removed all debris from the patient.
 
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Brand Name
BABY GORILLA/GORILLA PLATING SYSTEM
Type of Device
OLIVE WIRE
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 Key11213162
MDR Text Key229339987
Report Number3008650117-2021-00015
Device Sequence Number1
Product Code HXI
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K190365
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Physician
Type of Report Initial
Report Date 01/21/2021
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 NumberP99-201-1406
Device Catalogue NumberP99-201-1406
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/18/2020
Initial Date FDA Received01/22/2021
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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