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

Catalog Number 93329

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  Injury  

Manufacturer Narrative

The implanted device remains.

Event Description

Per the clinic, the patient experienced wound healing issues post implantation as a result the patient developed an ongoing infection at the implant site that was treated with oral antibiotics (date and duration not reported).Subsequently on (b)(6) 2016 the abutment was removed.

• Brand Name: FLANGE FIXTURE AND ABUTMENT
• Type of Device: LXB: PRODUCT CODE
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvagen 14; po box 82; moinlycke SE-43 5 22; SW SE-435 22
• Manufacturer Contact: nicole hille ; 13059 east peakview ave; centennial, CO 80111 ; 3037909010
• MDR Report Key: 5680701
• MDR Text Key: 45955630
• Report Number: 6000034-2016-01082
• 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: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 93329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2016
• 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