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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 Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 06/26/2020
Event Type  malfunction  
Manufacturer Narrative
The device history records for lot number 9152186 were reviewed. The issues identified are not related to the depth gauge breakage. Visual observation of the instrument confirmed the depth gauge broken into pieces. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
 
Event Description
A pargon 28 depth gauge plate screw, 70mm screw was reported broken after being washed. The needle of the device is snapped off completely. It was reported that the instrument was not broken in surgery.
 
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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
victoria akinboboye
14445 grasslands dr.
englewood, CO 80112
MDR Report Key11599786
MDR Text Key244404554
Report Number3008650117-2021-00074
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K190365
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 03/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2021
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 Manufacturer12/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2020
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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