MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	92128
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, during the implantation surgery on (b)(6) 2024, the surgery time was extended for 2 hours due to unable to screw an osia implant on the internal fixture.A back-up internal fixture was used with no further issues.

• Brand Name: BI300 IMPLANT 3MM
• Common Device Name: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• MDR Report Key: 19517325
• Report Number: 6000034-2024-02121
• Device Sequence Number: 18278079
• Product Code: LXB
• UDI-Device Identifier: 09321502019538
• UDI-Public: (01)09321502019538(10)COH1628579(17)280411
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2024
• Report Date (Section F): 06/12/2024

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: 92128
• Device Catalogue Number: 92128
• Device Lot Number: COH1628579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2024
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/15/2024
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2024
• 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: 9 YR
• Patient Sex: Female
• Date Report Sent to FDA: 06/12/2024