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

Catalog Number 90434

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

This report is filed april 10, 2014.

Event Description

Per the clinic, the patient experienced a loss of osseointegration (date not reported) resulting in fixture loss.On (b)(6) 2014, the patient underwent a surgical procedure to have an abutment attached to the 'sleeper' fixture.During the same procedure, a new 'sleeper' fixture was implanted.The device is not available for analysis.

Manufacturer Narrative

(b)(4).Device is not available for analysis.

• Brand Name: FLANGE FIXTURE AND ABUTMENT
• Type of Device: LXB
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvagen 14; po box 82; molnlycke, se 435- 22; SW 435-22
• Manufacturer Contact: renee hazelwood ; 13059 east peakview avenue; centennial, CO 80111 ; 3037909010
• MDR Report Key: 3593935
• MDR Text Key: 11736716
• Report Number: 6000034-2014-00173
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 90434
• Device Lot Number: 609108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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