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

Model Number	90434
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on september 8, 2020.
Event or Problem Description
Per the surgeon, the patient experienced skin granulation around the abutment and pain which was treated with a skin revision and the administration of antibiotics (type of administration unknown).The abutment was replaced with a longer abutment on (b)(6) 2020.

• Brand Name: FLANGE FIXTURE ST 4 MM W BAHA ABUTMENT
• Common Device Name: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 10500438
• Report Number: 6000034-2020-02395
• Device Sequence Number: 16833556
• Product Code: LXB
• UDI-Device Identifier: 09321502014359
• UDI-Public: (01)09321502014359(10)COH201124(17)07312016
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 08/21/2020

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 Expiration Date: 07/31/2016
• Device Model Number: 90434
• Device Catalogue Number: 90434
• Device Lot Number: COH201124
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR