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

Catalog Number 92135

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

This report is filed, (b)(6) 2016.The implanted device remains.

Event Description

Per the clinic, the patient experienced skin infections as well as wound healing issues related to external equipment.Subsequently on (b)(6) 2016 the abutment was removed.The implanted device remains.

Manufacturer Narrative

Per the clinic, the patient was prescribed antibiotics (dates and durations not reported) to treat infections at the implant site.During the (b)(6) 2016 abutment removal procedure, it was reported that excess tissue was excised from the site.The implanted device remains.

• Brand Name: FLANGE FIXTURE AND ABUTMENT
• Type of Device: LXB, PRODUCT CODE:
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke SE 43 5-22; SW SE 435-22
• Manufacturer Contact: nicole hille ; 13059 east peakview avenue; centennial, CO 80111 ; 3037909010
• MDR Report Key: 5478561
• MDR Text Key: 39627225
• Report Number: 6000034-2016-00506
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 92135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2016
• 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