MAUDE Adverse Event Report: PARAGON 28, INC. BABY GORILLA/GORILLA PLATING SYSTEM; ANTERIOR TT PLATE, STANDARD, FLAT, RIGHT, 08-HOLE

Model Number P53-401-R201

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Date 08/31/2022

Event Type  Injury  

Event Description

Plate broke during patient use.The plate was removed but the original surgery date was not confirmed by the complaint initiator.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Updated the adverse event problem codes.

• Brand Name: BABY GORILLA/GORILLA PLATING SYSTEM
• Type of Device: ANTERIOR TT PLATE, STANDARD, FLAT, RIGHT, 08-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: 15795275
• MDR Text Key: 303630733
• Report Number: 3008650117-2022-00132
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K190365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P53-401-R201
• Device Catalogue Number: P53-401-R201
• Device Lot Number: WV2009755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 11/01/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 80 KG