MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 12 MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93357

Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inadequate Osseointegration (2646); Skin Infection (4544)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on sept 23, 2022.

Event Description

Per the clinic, the patient did not keep the area around the implant clean after surgery, causing an infection.The infection was treated with oral antibiotics.The implant remains in-situ.

Manufacturer Narrative

Per the clinic, the patient experienced a loss of osseointegration.This report is submitted on october 21, 2022.

• Brand Name: BA300 ABUTMENT 12 MM
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; 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: mastura ruhanet ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 15492435
• MDR Text Key: 300641589
• Report Number: 6000034-2022-02798
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 93357
• Device Catalogue Number: 93357
• Device Lot Number: COH1349015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2022
• 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