• 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. GORILLA PLATING SYSTEM FIBULAR PLATE, STRAIGHT, 7-HOLE

  • 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. GORILLA PLATING SYSTEM FIBULAR PLATE, STRAIGHT, 7-HOLE Back to Search Results
Model Number P53-201-0007
Device Problems Break (1069); Appropriate Term/Code Not Available (3191)
Patient Problems Fall (1848); Bone Fracture(s) (1870); Joint Dislocation (2374)
Event Date 09/01/2021
Event Type  Injury  
Event Description
It was reported that 2 plates broke post-operatively. Original surgery date was (b)(6) 2021 and a medial distal tibia plate, 8-hole and fibular plate, straight, 7-hole was implanted. Patient reported falling in the shower and upon return to the doctor on (b)(6) 2021, the break was discovered. A revision surgery was completed on (b)(6) 2021 where the hardware was removed. Paragon 28 clinical evaluation of the provided radiographic images shows severe dislocation of a transverse tibia fracture. The distal tibia plate is broken approximately at the level of the tibia fracture at a filled screw hole. The fibular plate is broken above the level of the tibia fracture at the screw hole above the tibia fracture.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGORILLA PLATING SYSTEM
Type of DeviceFIBULAR PLATE, STRAIGHT, 7-HOLE
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 Key12558923
MDR Text Key274206642
Report Number3008650117-2021-00115
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K190365
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP53-201-0007
Device Catalogue NumberP53-201-0007
Device Lot NumberBR2101013
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/30/2021 Patient Sequence Number: 1
Treatment
P53-214-1008 MEDIAL DISTAL TIBIA PLATE, 8-HOLE
-
-