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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cellulitis (1768); Unspecified Infection (1930); Pain (1994); Swelling (2091); Patient Problem/Medical Problem (2688)

Event Date 02/18/2014

Event Type  Injury  

Manufacturer Narrative

This report is filed may 31, 2016.The implanted device remains.

Event Description

Per the clinic, the patient experienced recurrent skin issues at the abutment site.On (b)(6) 2014, the patient experienced granulation tissue and inflammation at the abutment site and was prescribed a topical antibiotic.On (b)(6) 2014 a hypertrophy scar was removed from the abutment site.On (b)(6) 2014, the patient was administered an injection of depo-medrol.On (b)(6) 2014, a keloid was removed from the site.On (b)(6) 2015, the patient experienced pain and swelling, as well as cellulitis at the abutment site and was prescribed oral antibiotics.On (b)(6) 2015, the patient experienced purulent discharge at the abutment site and was prescribed another course of oral antibiotics.The patient developed subcutaneous scar tissue at the site which was excised on (b)(6) 2016.On (b)(6) 2016, the patient reported pain at the abutment site due to a hypertrophic scar and the site was injected with steroids.The implanted device remains.

• Brand Name: FLANGE 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: angel wright ; 13059 east peakview avenue; centennial, CO 80111 ; 3037909010
• MDR Report Key: 5688547
• MDR Text Key: 46192722
• Report Number: 6000034-2016-01062
• 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: Physician
• Type of Report: Initial
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• 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: 90434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2016
• 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: 35 YR