MAUDE Adverse Event Report: PARAGON 28, INC BABY GORILLA/GORILLA PLATING SYSTEM; BABY GORILLA, SCREW, Ø2.5 X 12MM, NON-LOCKING, TIA

Model Number P50-153-2510

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

Part inside of temporary packaging did not match the temporary packaging label.

• Brand Name: BABY GORILLA/GORILLA PLATING SYSTEM
• Type of Device: BABY GORILLA, SCREW, Ø2.5 X 12MM, NON-LOCKING, TIA
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: jenny conger ; 14445 grasslands dr; englewood, CO 80112 ; 7203721212
• MDR Report Key: 13183997
• MDR Text Key: 284918711
• Report Number: 3008650117-2022-00000
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K190365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P50-153-2510
• Device Catalogue Number: P50-153-2510
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2021
• 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