• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 06/29/2021
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
After drilling, the depth gauge was broken while attempting to measure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
7207165439
MDR Report Key12205084
MDR Text Key264951569
Report Number3008650117-2021-00098
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial
Report Date 07/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2021
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 Number9152814
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2021
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 Unkown

-
-