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

Model Number M51137

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 09/04/2015

Event Type  No Answer Provided  

Event Description

Surgeon was to swap out 9mm abutment for 12 mm abutment.When surgeon attempted the switch out the entired implant came out.Patient was re-implanted on (b)(6) 2015.

• Brand Name: PONTO IMPLANT WITH ABUTMENT
• Type of Device: BONE ANCHORED HEARING IMPLANT
• Manufacturer (Section D): OTICON MEDICAL AB; datavägen 37b; askim, västra götaland 436 3 2; SW 436 32
• Manufacturer (Section G): OTICON MEDICAL AB; datavägen 37b; askim, västra götaland 436 3 2; SW 436 32
• Manufacturer Contact: patrik löfqvist ; datavägen 37b; askim, västra götaland 436 3-2 ; SW 436 32 ; 6317486100
• MDR Report Key: 5155620
• MDR Text Key: 28449971
• Report Number: 3007367732-2015-00041
• Device Sequence Number: 1
• Product Code: MAH
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2015,10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2019
• Device Model Number: M51137
• Device Catalogue Number: M51137
• Device Lot Number: 145021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/09/2015
• Device Age: 3 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/05/2015
• Date Manufacturer Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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