MAUDE Adverse Event Report: MEDTRONIC XOMED UNIVERSAL TITANIUM PROSTHESIS

Model Number REF 1150001

Device Problems Break (1069); Device remains implanted (1526)

Patient Problem Hearing Loss (1882)

Event Date 09/29/2014

Event Type  malfunction  

Event Description

Universal titanium prosthesis, cam head, with flex h/a titanium shoe broke while being implanted in the pt' ear.A small metal piece was lost in the middle ear and the dr was unable to visualize it and said, "i cannot find it and if i go digging around i can cause more damage." so the decision was made not to retrieve it.

• Brand Name: UNIVERSAL TITANIUM PROSTHESIS
• Type of Device: UNIVERSAL TITANIUM PROSTHESIS
• Manufacturer (Section D): MEDTRONIC XOMED; 4102 southpoint blvd; jacksonville FL 32216 092
• MDR Report Key: 4321044
• MDR Text Key: 5134413
• Report Number: 4321044
• Device Sequence Number: 1
• Product Code: ETA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2021
• Device Model Number: REF 1150001
• Device Lot Number: 0207296386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/25/2014
• Distributor Facility Aware Date: 09/29/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 50