MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 14MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93337
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Granuloma (1876); Inflammation (1932); Pain (1994); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient developed skin overgrowth, pain and inflammation at the abutment site.The patient underwent steroid injections in (b)(6) 2025 (specific date not reported) at the abutment site.The patient was also treated with topical steroids and topical antibiotics (specific date and duration not reported) to manage reported issue.In addition, a skin revision procedure (specific date not reported) was performed to improve local tissue condition and abutment healing.Additional information has been requested but has not been made available as of the date of this report.
Additional Manufacturer Narrative
The clinic reported that the patient received steroid injections to the abutment site on (b)(6) 2025, (b)(6) 2025, (b)(6) 2025 and (b)(6) 2025.The patient was also treated with oral antibiotics on (b)(6) 2025 and(b)(6) 2025 for ten days each.
Additional Manufacturer Narrative
Per the clinic, the patient underwent revision surgery and abutment replacement procedure on (b)(6) 2025 under general anesthesia.During the procedure, the abutment was removed, substantial subcutaneous granulation tissue was debrided, hypertrophic scar tissue was excised, and a new abutment was placed on the existing internal fixture.Subsequently, the patient received an injectable steroid around the incision site (specific date and duration not reported).

• Brand Name: BA400 ABUTMENT 14MM
• 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: hema dewi ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 23519347
• Report Number: 6000034-2025-04067
• Device Sequence Number: 21320782
• Product Code: MAH
• UDI-Device Identifier: 09321502033459
• UDI-Public: (01)09321502033459(10)181136(17)231030
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K121317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2026

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: 93337
• Device Catalogue Number: 93337
• Device Lot Number: 181136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 11/15/2025; 01/07/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/15/2025; 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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