MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FIXTURE ST 4MM; COCHLEAR BAHA VISTAFIX SYSTEM

Model Number 90440

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Date 07/23/2022

Event Type  Injury  

Manufacturer Narrative

The reported adverse 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.Implant loss with baha implants can occur at any time following implantation.Known reasons for implant loss include lack of adequate bone quality/quantity, trauma, infection, generalised diseases and surgical complication.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 september 06, 2022.

Event Description

Per the clinic, the patient experienced a loss of osseointegration subsequent to a head trauma.It is unknown if there are plans to reimplant the patient as of the date of this report.Additional information has been requested but it has not been made available as of the date of this report.

• Brand Name: FIXTURE ST 4MM
• Type of Device: COCHLEAR BAHA VISTAFIX 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 ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 15359113
• MDR Text Key: 299277356
• Report Number: 6000034-2022-02593
• Device Sequence Number: 1
• Product Code: FZE
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K945154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 90440
• Device Catalogue Number: 90440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Date Manufacturer Received: 08/16/2022
• 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
• Patient Age: 88 YR
• Patient Sex: Male