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

Catalog Number 92133

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced skin overgrowth on the abutment.Subsequently, the patient underwent a procedure in (b)(6) 2014 (date not reported), to excise the excess skin.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: 4353643
• MDR Text Key: 5172689
• Report Number: 6000031-2014-01789
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2014

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: 92133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 12/22/2014
• 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