MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA310 IMPLANT 4 MM WITH ABUTMENT 10 MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	BIA310
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted onjun 27, 2019.(b)(4).
Event or Problem Description
Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss.It is unknown if there are plans to re-implant the patient with a new device as of the date of this report.
Additional Manufacturer Narrative
This report is submitted on august 22, 2019.

• Brand Name: BIA310 IMPLANT 4 MM WITH ABUTMENT 10 MM
• 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: 8737812
• Report Number: 6000034-2019-01028
• Device Sequence Number: 11406297
• Product Code: LXB
• UDI-Device Identifier: 09321502043922
• UDI-Public: (01)09321502043922(10)COH1233465(17)230626
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K121317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2019

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: BIA310
• Device Catalogue Number: ASKU
• Device Lot Number: COH1233465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/21/2019
• 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