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

Model Number M52173

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Infiltration into Tissue (1931)

Event Date 12/19/2016

Event Type  No Answer Provided  

Event Description

Patient implanted (b)(6) 2016 using a two stage procedure.In (b)(6) 2016 surgeon connected 12mm abutment, with difficulty.Abutment came off on (b)(6) 2016.Surgeon tried to reconnect a new 12 mm abutment using local injection and clearing tissue from the implant site, however he could not get the abutment to hex lock.He will revise the site in (b)(6) 2017 using a premounted abutment.

• Brand Name: PONTO
• 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: anna borg ; datavägen 37b; askim, västra götaland SE-43-6 32 ; SW SE-436 32 ; 6317486100
• MDR Report Key: 6265981
• MDR Text Key: 65344369
• Report Number: 3007367732-2017-00008
• Device Sequence Number: 1
• Product Code: MAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M52173
• Device Catalogue Number: M52173
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/19/2016
• Device Age: 7 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/22/2016
• Date Manufacturer Received: 12/22/2016
• 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 Age: 73 YR