MAUDE Adverse Event Report: PARAGON 28, INC. GORILLA PLATING SYSTEM; MEDIAL DISTAL TIBIA PLATE, 8-HOLE

Model Number P53-214-1008

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Hip Fracture (2349)

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.

• Brand Name: GORILLA PLATING SYSTEM
• Type of Device: MEDIAL DISTAL TIBIA PLATE, 8-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 Key: 12558920
• MDR Text Key: 274205396
• Report Number: 3008650117-2021-00114
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K203511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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 Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P53-214-1008
• Device Catalogue Number: P53-214-1008
• Device Lot Number: PA2020002382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2021
• 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 Sequence Number: 1
• Treatment: P53-201-0007 FIBULAR PLATE, STRAIGHT, 7-HOLE
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 80