• 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 08/28/2020
Event Type  malfunction  
Manufacturer Narrative
The device history record for lot number 9155987 was reviewed and shows all inspected parts were received and accepted. No ncr identified on dhr. Devices are not expected to be returned for the manufacturer review/investigation because it was discarded by the facility. 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 depth gauge was broken when it was returned from the hospital and the needle of the device is snapped off completely. It was reported that the instrument was not broken in surgery.
 
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
MDR Report Key11598564
MDR Text Key244442500
Report Number3008650117-2021-00072
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 Number9155987
Was Device Available for Evaluation? No
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? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-