MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA210 FLANGE FIXTURE ST 3MM W ABUTMENT 5.5MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92135

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Necrosis (1971); Pain (1994)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a skin necrosis.Additional information has been requested but it has not been made available as of the date of this report.

Manufacturer Narrative

This report is submitted on january 26, 2024.

Manufacturer Narrative

Per the clinic, the patient experienced an infection and pain at the implant site.Subsequently, the device was explanted on (b)(6) 2024.The reported adverse event is associated with a returned device; however, the provided clinical information was reviewed by the manufacturer and no specific device analysis is deemed necessary at this time.Previous product examinations have not showed any relationship between a product geometrical deviation and the reported clinical complication.Additionally, there are no indications that a product failure has contributed to the reported issue.Transient pain is a known medical complication where most cases can be resolved with clinical case management.Known reasons for cause of pain are abnormal skin sensitivity, earlier trauma to the implanted area, lack of adequate bone quality or other generalized diseases.It might also be due to a loose implant magnet, causing pain around the implanted area when using the baha sound processor.Adverse skin reactions around the baha abutment, ranging from slight redness to infected tissue, are common complications with baha implants, and can occur at any time following implantation.The report frequency for these complications is being monitored under cbas complaint and medical device reporting data monitoring plan and the status is updated on a monthly basis.This event is added to this monitoring.This report is submitted on march 25, 2024.

• Brand Name: BIA210 FLANGE FIXTURE ST 3MM W ABUTMENT 5.5MM
• 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: mastura ruhanet ; konstruktionsvägen 14; no. 8 jalan kerinchi,; mölnlycke, 435 3-3 ; SW 435 33
• MDR Report Key: 18585742
• MDR Text Key: 333771809
• Report Number: 6000034-2024-00310
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121317
• 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: 02/29/2024

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: 92135
• Device Catalogue Number: 92135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/24/2024
• Was Device Evaluated by Manufacturer?: No
• 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