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

Device Problem Disconnection (1171)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Type  No Answer Provided  

Event Description

Implant pulled out during surgery due to instrument not disconnecting.

• Brand Name: PONTO IMPLANT WITH ABUTMENT
• Type of Device: BONE ANCHORED HEARING IMPLANT
• Manufacturer (Section D): OTICON MEDICAL AB; ekonomivagen 2; askim SE-4 36; SW SE-436
• Manufacturer Contact: karolin jernby ; ekonomivagen 2; askim SE-43-6 44 ; SW SE-436 44 ; 17486153
• MDR Report Key: 3601563
• MDR Text Key: 4090238
• Report Number: 3007367732-2014-00001
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/08/2014

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: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/08/2013
• Initial Date Manufacturer Received: 05/08/2013
• Initial Date FDA Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention