MAUDE Adverse Event Report: PARAGON 28, INC. BABY GORILLA®/GORILLA® PLATING SYSTEM; SILVERBACK LOCKING PLATE SCREW, 4.5

Model Number P50-553-45XX

Device Problem Unstable (1667)

Patient Problem Failure of Implant (1924)

Event Date 11/11/2021

Event Type  Injury  

Manufacturer Narrative

Clinical evaluation of the provided radiographic images completed; plate breakage is observed at the level of the interface between the cage and the talus.Screw breakage is observed in the two proximal tibia screws, with the remaining screw intact in the tibia.User error is indicated because a crossing screw was not used.Use of a crossing screw is required for this procedure.

Event Description

Report of a post-operative break of a lateral ttc plate and 2 silverback locking plate screws.A revision surgery was completed to remove all the hardware.

Manufacturer Narrative

Clinical evaluation of the provided radiographic images completed; plate breakage is observed at the level of the interface between the cage and the talus.Screw breakage is observed in the two proximal tibia screws, with the remaining screw intact in the tibia.User error is indicated because a crossing screw was not used.Use of a crossing screw is required for this procedure.

Event Description

Report of a post-operative break of a lateral ttc plate and 2 silverback locking plate screws.A revision surgery was completed to remove all the hardware.

Manufacturer Narrative

Clinical evaluation of the provided radiographic images completed; plate breakage is observed at the level of the interface between the cage and the talus.Screw breakage is observed in the two proximal tibia screws, with the remaining screw intact in the tibia.User error is indicated because a crossing screw was not used, use of a crossing screw is required for this procedure.However, per clinical, this was a limb salvage case.Use of a cage in this case did not allow the surgeon to use a crossing screw.

• Brand Name: BABY GORILLA®/GORILLA® PLATING SYSTEM
• Type of Device: SILVERBACK LOCKING PLATE SCREW, 4.5
• 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: 12981624
• MDR Text Key: 285324298
• Report Number: 3008650117-2021-00137
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K190365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P50-553-45XX
• Device Catalogue Number: P50-553-45XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male