MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92127

Device Problems Loss of Osseointegration (2408); Appropriate Term/Code Not Available (3191)

Patient Problems Inadequate Osseointegration (2646); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced swelling at the implant site and was subsequently treated with topical antibiotics (specific date and duration not reported).Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

This report is submitted on september 07, 2022.

Manufacturer Narrative

Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss (specific date not reported).The patient was placed under general anesthesia in order to be reimplanted with another cochlear device on (b)(6) 2022.This report is submitted on october 20, 2022.

• Brand Name: BA400 ABUTMENT 6MM
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: thanaletchumi manogaran ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 15367617
• MDR Text Key: 299353081
• Report Number: 6000034-2022-02570
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

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 Model Number: 92127
• Device Catalogue Number: 92127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: 09/27/2022
• Supplement Dates FDA Received: 10/20/2022
• 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 Sex: Female