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

Model Number	90432
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss on (b)(6) 2019.There are plans to reimplant the patient with a new device; however has yet to occur as of the date of this report.

• Brand Name: FLANGE FIXTURE ST 4MM
• 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: 8300616
• Report Number: 6000034-2019-00140
• Device Sequence Number: 47037
• Product Code: MAH
• UDI-Device Identifier: 09321502012904
• UDI-Public: (01)09321502012904(10)005CMC
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K955713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/21/2019

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: 90432
• Device Catalogue Number: 90432
• Device Lot Number: 005CMC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 02/03/2019
• 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
• Patient Age: 48 YR