MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT; COCHLEAR BAHA CONNECT SYSTEM

Model Number 90434

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Date 11/18/2021

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss on (b)(6) 2021.There are no plans to reimplant the patient with a new device as of the date of this report.

• Brand Name: FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• MDR Report Key: 13104601
• MDR Text Key: 282893713
• Report Number: 6000034-2021-03917
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502014359
• UDI-Public: (01)09321502014359(10)606518(17)120301
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2021,12/08/2021

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 Expiration Date: 03/01/2012
• Device Model Number: 90434
• Device Catalogue Number: 90434
• Device Lot Number: 606518
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2021
• Distributor Facility Aware Date: 12/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female