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

Model Number 92128

Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inadequate Osseointegration (2646); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on august 02, 2021.

Event Description

Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss.Subsequently, the patient was placed under general anesthesia in order to explant the fixture and implant magnet (date not reported).It is unknown if there are plans to reimplant the patient as of the date of this report.

Manufacturer Narrative

Correction: per the clinic, it has been confirmed that there is no reported loss of osseointegration.This report is submitted on november 30, 2021.

• 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 3 3; SW 435 33
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; 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: 12257720
• MDR Text Key: 264462881
• Report Number: 6000034-2021-02279
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502019538
• UDI-Public: (01)09321502019538(10)COH1129963(17)220701
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

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 Expiration Date: 07/01/2022
• Device Model Number: 92128
• Device Catalogue Number: 92128
• Device Lot Number: COH1129963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 11/29/2021
• 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
• Patient Sex: Male