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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 Problems Break (1069); Difficult to Remove (1528)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/10/2021
Event Type  malfunction  
Manufacturer Narrative
Product evaluation confirmed the alleged failure mode. If further information is identified which would change or alter information or conclusions, a supplemental report will be filed accordingly.
 
Event Description
Depth gauge broke during surgery and the tip was left in the patient.
 
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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 Key12240779
MDR Text Key265990615
Report Number3008650117-2021-00101
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeSN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 07/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2021
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 Number9152186
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2021
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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