MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM

Model Number	92133
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Host-Tissue Reaction (1297)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Per the audiologist, the patient experienced skin overgrowth at the abutment site.Subsequently the abutment was removed and a longer abutment was placed on (b)(6) 2018.During the procedure a skin revision was performed with the administration of iv antibiotics and the use of mild iv sedation.The patient was prescribed oral antibiotics for a week.

• Brand Name: BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE
• 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: 7505277
• Report Number: 6000034-2018-00988
• Device Sequence Number: 1775148
• Product Code: MAH
• UDI-Device Identifier: 09321502018968
• UDI-Public: (01)09321502018968(10)COH1073939(17)220113
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K121317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date (Section B): 04/24/2018

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: 01/13/2022
• Device Model Number: 92133
• Device Catalogue Number: 92133
• Device Lot Number: COH1073939
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2014
• Initial Report FDA Received Date: 05/10/2018
• 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: 15 YR