MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 10MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93331
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on july 28, 2022.
Event or Problem Description
Per the clinic, the patient experienced infection and skin overgrowth at the abutment site (date not reported).The patient was treated with oral and iv antibiotics, however the issue did not resolve.Subsequently, the patient underwent a skin revision surgery under general anaesthesia on (b)(6) 2022.The implanted device remains.
Additional Manufacturer Narrative
Per the clinic, the issue has not resolved.The patient was hospitalized overnight on (b)(6) 2022, for an iv antibiotic treatment.Subsequently, the patient was placed under general anesthesia for a second time on (b)(6) 2022, in order to remove the abutment and granulated skin.The symptoms resolved, and the patient resumed use of the device.No additional episodes were reported.This report is submitted on november 07, 2022.

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 10MM
• 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: thanaletchumi manogaran ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 15118972
• Report Number: 6000034-2022-02206
• Device Sequence Number: 17972600
• Product Code: MAH
• UDI-Device Identifier: 09321502019620
• UDI-Public: (01)09321502019620(10)COH1208992(17)230405
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

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 Expiration Date: 04/05/2023
• Device Model Number: 93331
• Device Catalogue Number: 93331
• Device Lot Number: COH1208992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 11/07/2022
• 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; Hospitalization
• Patient Sex: Female