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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC BABY GORILLA/GORILLA PLATING SYSTEM DEPTH GAUGE PLATE SCREW, 70MM SCREW

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PARAGON 28, INC BABY GORILLA/GORILLA PLATING SYSTEM DEPTH GAUGE PLATE SCREW, 70MM SCREW Back to Search Results
Model Number P99-150-0014
Device Problem Fracture (1260)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/20/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Preferred term: unknown. Limited information is available and it is unknown if the product malfunction occurred during a procedure.
 
Event Description
Limited information - a depth gauge with a broken tip was found while conducting stock inventory.
 
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Brand NameBABY GORILLA/GORILLA PLATING SYSTEM
Type of DeviceDEPTH GAUGE PLATE SCREW, 70MM SCREW
Manufacturer (Section D)
PARAGON 28, INC
14445 grasslands dr
englewood CO 80112
Manufacturer Contact
jenny conger
14445 grasslands dr
englewood, CO 80112
7203721212
MDR Report Key13545902
MDR Text Key286502651
Report Number3008650117-2022-00024
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP99-150-0014
Device Catalogue NumberP99-150-0014
Device Lot Number9152814
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2022
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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