MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU; COCHLEAR BAHA CONNECT SYSTEM

Model Number ASKU

Device Problem Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on aug 25, 2021.

Event Description

Per the clinic, the patient experienced a loss of osseointegration on (specific date not reported) resulting in fixture loss.Subsequently, the abutment was removed on (b)(6) 2021 under a local/mac anaesthetic and the patient was replaced with a new abutment.

• Brand Name: ASKU
• Type of Device: 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: durga velayutham ; unit ug-1, vertical podium; no.8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 12363899
• MDR Text Key: 268033536
• Report Number: 6000034-2021-02599
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention