MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM

Device Problem Appropriate Term/Code Not Available (3191)

Event Date 11/08/2023

Event Type  Injury  

Manufacturer Narrative

No info received to perform analyis.No lot, x-rays, devices or other info received.

Event Description

The patient came in reporting pain.The surgeon observed that the proximal peripheral screw was too long and that there was a fragmented piece of bone inferiorly that was being impinged upon during range of motion.The surgeon revised the glenosphere, liner, glenoid polyaxial screw, and reverse metaphysis screw.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM
• Type of Device: REVERSE SHOULDER SYSTEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18266623
• MDR Text Key: 329727397
• Report Number: 3005180920-2023-00969
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 64 YR
• Patient Sex: Female