MAUDE Adverse Event Report: COCHLEAR BAHA SCREW/ABUTMENT

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Swelling (2091)

Event Date 12/21/2014

Event Type  Injury  

Event Description

The baha implant by cochlear came out of my skull.I have indentation and a swollen lump at the site and it is still painful.I'd like to have the surgery redone but, would have to repay and cannot afford to do that.It was very painful.I still have the screw, abutment, and cap.I was also told that another patient that had implant put in the same day also had hers to fall out.I have no way of knowing what lot my equipment came from.

• Brand Name: BAHA SCREW/ABUTMENT
• Type of Device: BAHA SCREW/ABUTMENT
• Manufacturer (Section D): COCHLEAR
• MDR Report Key: 4508612
• MDR Text Key: 5441426
• Report Number: MW5040669
• Device Sequence Number: 1
• Product Code: LXB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/05/2015

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: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 88