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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC GORILLA PLATING SYSTEM; 3.5 X 24 MM R3CON NON-LOCKING PLATE SCREW

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PARAGON 28, INC GORILLA PLATING SYSTEM; 3.5 X 24 MM R3CON NON-LOCKING PLATE SCREW Back to Search Results
Catalog Number P50-453-3524
Device Problem Unintended Movement (3026)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/19/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
A post market clinical study identified screw backed out of plate.Clinical notes state the subject was non-complaint with weight-bearing protocol.
 
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Brand Name
GORILLA PLATING SYSTEM
Type of Device
3.5 X 24 MM R3CON NON-LOCKING PLATE SCREW
Manufacturer (Section D)
PARAGON 28, INC
14445 grasslands dr
englewood CO 80112
Manufacturer Contact
jenny conger
14445 grasslands dr
englewood, CO 80112
MDR Report Key15117170
MDR Text Key297231463
Report Number3008650117-2022-00096
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study
Reporter Occupation Physician
Type of Report Initial
Report Date 07/27/2022
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? Yes
Device Catalogue NumberP50-453-3524
Device Lot NumberAX01192
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/29/2022
Initial Date FDA Received07/27/2022
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
Patient Age45 YR
Patient SexMale
Patient Weight136 KG
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