MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET; COCHLEAR BAHA ATTRACT SYSTEM

Model Number 93550

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Tissue Breakdown (2681)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a skin flap breakdown.The patient underwent revision surgery on (b)(6) 2021, in order to convert the patient to a transcutaneous osia implant system.During the procedure, the internal magnet was removed, and an implant was placed on the internal fixture.

Event Description

Per the clinic, the patient was treated with iv antibiotics (duration not reported) on (b)(6) 2021.

• Brand Name: BIM400 IMPLANT MAGNET
• Type of Device: COCHLEAR BAHA ATTRACT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 3 3; SW 435 33
• MDR Report Key: 12316862
• MDR Text Key: 266360811
• Report Number: 6000034-2021-02617
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502025294
• UDI-Public: (01)09321502025294(10)126396(17)220630
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 09/01/2021,08/12/2021

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 Expiration Date: 06/30/2022
• Device Model Number: 93550
• Device Catalogue Number: 93550
• Device Lot Number: 126396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2021
• Distributor Facility Aware Date: 08/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention