MAUDE Adverse Event Report: OTICON MEDICAL AB PONTO IMPLANT WITH ABUTMENT; BONE ANCHORED HEARING IMPLANT

Model Number M51137

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 02/12/2016

Event Type  No Answer Provided  

Manufacturer Narrative

There are no indications that the occurred is a result of manufacturing or component failure.These incidents are not considered as safety issues, but they are reported due to the intervention required for the patient to be able to continue using the bone anchored hearing system.

Event Description

The position of the original implant resulted in the sound processor creating feedback.The abutment was removed from the implant.Implant left in situ.New implant & abutment placed.

• Brand Name: PONTO IMPLANT WITH ABUTMENT
• Type of Device: BONE ANCHORED HEARING IMPLANT
• Manufacturer (Section D): OTICON MEDICAL AB; datavägen 37b; askim, västra götaland SE-43 6 32; SW SE-436 32
• Manufacturer (Section G): OTICON MEDICAL AB; datavägen 37b; askim, västra götaland SE-43 6 32; SW SE-436 32
• Manufacturer Contact: patrik löfqvist ; datavägen 37b; askim, västra götaland SE-43-6 32 ; SW SE-436 32 ; 6317486167
• MDR Report Key: 5479016
• MDR Text Key: 39627820
• Report Number: 3007367732-2016-00008
• Device Sequence Number: 1
• Product Code: MAH
• Combination Product (y/n): N
• PMA/PMN Number: K121228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 02/12/2016

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: 11/01/2018
• Device Model Number: M51137
• Device Catalogue Number: M51137
• Device Lot Number: 134807
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/12/2016
• Date Report to Manufacturer: 02/12/2016
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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 Age: 71 YR