MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA FLANGE FIXTURE AND ABUTMENT; LXB: PRODUCT CODE

Catalog Number 92129

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Dizziness (2194); No Information (3190)

Event Date 06/16/2014

Event Type  Injury  

Event Description

It was reported, the patient experienced soreness at the implant site and dizziness.On (b)(6), 2014, the patient was prescribed oral antibiotics (duration not reported).The implanted device remains.

Manufacturer Narrative

(b)(4).The implanted device remains.

• Brand Name: BAHA FLANGE FIXTURE AND ABUTMENT
• Type of Device: LXB: PRODUCT CODE
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvagen 14; po box 82; moinlycke SE-4 35 2; SW SE-435 22
• Manufacturer Contact: nicole hille ; 13059 east peakview ave; centennial, CO 80111 ; 3037909010
• MDR Report Key: 4009964
• MDR Text Key: 21445343
• Report Number: 6000034-2014-01131
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Type of Report: Initial
• Report Date: 07/25/2014

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
• Device Catalogue Number: 92129
• Device Lot Number: 122699
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2014
• Initial Date FDA Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: No
• 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: 53 YR