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

Model Number	90434
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Purulent Discharge (1812); Pain (1994); Inadequate Osseointegration (2646); Skin Infection (4544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on january 06, 2023.
Event or Problem Description
Per the clinic, the patient experienced pain and drainage around implant site and subsequently was treated with oral and topical antibiotics for two weeks (specific date not reported).It was also reported that the patient experienced a loss of osseointegration resulting in fixture loss.The patient also experienced an infection at the implant site resulting in the decision to explant the device.The device was explanted on (b)(6) 2022 and there are no plans to re-implant the patient with a new device as of the date of this report.

• Brand Name: FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT
• Common Device Name: 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: kalai tamilselvan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 16110692
• Report Number: 6000034-2023-00112
• Device Sequence Number: 5743505
• Product Code: LXB
• UDI-Device Identifier: 09321502014359
• UDI-Public: (01)09321502014359(10)002CMC(17)600412
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K955713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 90434
• Device Catalogue Number: 90434
• Device Lot Number: 002CMC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male