MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 14MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93338

Device Problem Failure to Osseointegrate (1863)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/01/2019

Event Type  Injury  

Event Description

Per the clinic, it was reported that the patient experienced a lack of osseointegration resulting in fixture loss on (b)(6) 2019.It is unknown whether the patient was reimplanted, as of the date of this report.

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 14MM
• Type of Device: 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: 9107816
• MDR Text Key: 160503311
• Report Number: 6000034-2019-01855
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2019,09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 93338
• Device Catalogue Number: 93338
• Device Lot Number: COH125409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2019
• Distributor Facility Aware Date: 09/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR