BI300 IMPLANT 3MM 92128

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for BI300 IMPLANT 3MM 92128 manufactured by Cochlear Bone Anchored Solutions Ab.

Event Text Entries

[185952071] Per the clinic, it was reported that the patient experienced a lack of osseointegration resulting in fixture loss due to compromised bone and localised site granulation. The patient was treated with topical medication following the fixture loss (type not reported). It is unknown whether there are plans to reimplant the patient, as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6000034-2020-00933
• MDR Report Key: 9881578
• Date Received: 2020-03-25
• Date of Report: 2020-03-02
• Date Facility Aware: 2020-03-02
• Report Date: 2020-03-26
• Date Reported to FDA: 2020-03-26
• Date Reported to Mfgr: 2020-03-26
• Date Added to Maude: 2020-03-25
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BI300 IMPLANT 3MM
• Generic Name: COCHLEAR BAHA CONNECT SYSTEM
• Product Code: LXB
• Date Received: 2020-03-25
• Returned To Mfg: 2020-03-12
• Model Number: 92128
• Catalog Number: 92128
• Lot Number: NI
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COCHLEAR BONE ANCHORED SOLUTIONS AB
• Manufacturer Address: KONSTRUKTIONSV?GEN 14 PO BOX 82 M?LNLYCKE, 435 22 SW 435 22

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-25