MAUDE Adverse Event Report: OTICON MEDICAL AB ABUTMENT INSERTER; BONE ANCHORED HEARING SYSTEM

Model Number M50533

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2014

Event Type  Other  

Event Description

Implant pulled out during surgery.

• Brand Name: ABUTMENT INSERTER
• Type of Device: BONE ANCHORED HEARING SYSTEM
• Manufacturer (Section D): OTICON MEDICAL AB; ekonomivagen 2; askim SE-4 36 3; SW SE-436 33
• Manufacturer Contact: carolina wessling ; ekonomivagen 2; askim SE-43-6 33 ; SW SE-436 33 ; 17486175
• MDR Report Key: 3853789
• MDR Text Key: 4620183
• Report Number: 3007367732-2014-00022
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/09/2014

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
• Device Model Number: M50533
• Device Catalogue Number: M50533
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 05/28/2014
• 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