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

Catalog Number 92128

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 02/23/2015

Event Type  Injury  

Event Description

Per the clinic, the patient experienced post op csf leakage.The patient underwent an exploration surgery on (b)(6) 2015, to seal the leak.The implanted device remained insitu at all times.

Manufacturer Narrative

(b)(4).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, 435 2 2; SW 435 22
• Manufacturer Contact: rebekka jeger ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109 ; 1294286300
• MDR Report Key: 4640089
• MDR Text Key: 15127512
• Report Number: 6000034-2015-00560
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K100360
• 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: 03/03/2015

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: 92128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2015
• Initial Date FDA Received: 03/30/2015
• 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