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

Model Number 92128

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on october 2, 2019.

Event Description

Per the clinic, it was reported that the patient sustained a trauma at the implant site, following a fall.Subsequent to the impact, an infection developed at the implant site.Revision surgery is planned; however, yet to occur as of the date of this report.

Manufacturer Narrative

Per the clinic, the patient's reported infection was treated with antibiotics.This report is submitted october 29, 2019.

• Brand Name: BI300 IMPLANT 3MM
• 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: 9143761
• MDR Text Key: 160903463
• Report Number: 6000034-2019-02035
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 92128
• UDI-Public: (01)92128(10)COH1089596(17)211209
• Combination Product (y/n): N
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/09/2021
• Device Model Number: 92128
• Device Catalogue Number: 92128
• Device Lot Number: COH1089596
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 10/02/2019
• Supplement Dates FDA Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention