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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Fistula (1862)

Event Date 05/01/2014

Event Type  Injury  

Event Description

Per the clinic, the patient developed an infection and subsequent fistula around the implant site.The patient was prescribed oral antibiotics in (b)(6) 2014 (duration and exact date not reported).The implanted device remains.

Manufacturer Narrative

(b)(4).Implanted device remains.

• Brand Name: BAHA FIXTURE AND ABUTMENT
• Type of Device: LXB
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, se 435-2 2; SW 435-22
• Manufacturer Contact: caleb matthews ; 13059 peakview ave; centennial, CO 80111 ; 3037909010
• MDR Report Key: 4587264
• MDR Text Key: 15960546
• Report Number: 6000034-2015-00342
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date: 02/19/2015

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 92134
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2015
• Initial Date FDA Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 22 YR