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

Catalog Number 92135

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Breakdown (2681)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a skin flap breakdown (date not reported).The implanted device remains.

Manufacturer Narrative

(b)(4).Implanted device remains.

• Brand Name: FLANGE FIXTURE AND ABUTMENT
• Type of Device: LXB, PRODUCT CODE: LXB, PRODUCT CODE:LXB
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvagen 14; po box 82; molnlycke, se 435 22; SW 435 22
• Manufacturer Contact: jennifer campo ; 13059 east peakview ave.; centennial, CO 80111 ; 3037909010
• MDR Report Key: 4343268
• MDR Text Key: 17693492
• Report Number: 6000031-2014-01756
• 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: 12/03/2014

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: Lay User/Patient
• Device Catalogue Number: 92135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: No
• 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