MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR OSIA OSI200 IMPLANT; COCHLEAR¿ OSIA¿ SYSTEM

Model Number OSI200

Device Problems Loss of Osseointegration (2408); Expulsion (2933)

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

Event Date 12/07/2022

Event Type  Injury  

Manufacturer Narrative

This report is submitted on january 30, 2023.

Event Description

Per the clinic, the patient experienced crusting over the implant.Once the crusting was removed the implant was shown to be protruding.There was loss of osseointegration of the implant.There was an infection at the site that was treated with oral and topical antibiotics.The device was explanted under a general anaesthetic on (b)(6) 2023.There are plans to re-implant the patient.

• Brand Name: COCHLEAR OSIA OSI200 IMPLANT
• Type of Device: COCHLEAR¿ OSIA¿ SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsv[?]gen 14; m[?]lnlycke, 435 3 3; SW 435 33
• MDR Report Key: 16261740
• MDR Text Key: 308343419
• Report Number: 6000034-2023-00289
• Device Sequence Number: 1
• Product Code: PFO
• UDI-Device Identifier: 09321502046152
• UDI-Public: (01)09321502046152(11)210601(17)230531
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2023,01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Model Number: OSI200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2023
• Distributor Facility Aware Date: 01/10/2023
• Date Report to Manufacturer: 01/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female