MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB 4MM IMPLANT SCREW; HEARING AID, BONE CONDUCTION

Lot Number COH1450399

Device Problem Defective Component (2292)

Patient Problem Failure of Implant (1924)

Event Date 10/12/2021

Event Type  malfunction  

Event Description

The hole for the 4mm screw was drilled into the patient¿s skull, widened with a countersink and 4mm screw was inserted with the low speed torque adjusted drill.60+ attempts to place a device and insert the 2nd screw failed.It was therefore decided that the 4mm screw was likely defective and a second screw was inserted just 1cm inferior to it.

• Brand Name: 4MM IMPLANT SCREW
• Type of Device: HEARING AID, BONE CONDUCTION
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; 10350 park meadows drive; lone tree CO 80124
• MDR Report Key: 12786470
• MDR Text Key: 280593261
• Report Number: 12786470
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: COH1450399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Sex: Male
• Patient Ethnicity: Hispanic