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

Model Number M51138

Device Problems Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949)

Patient Problem No Code Available (3191)

Event Date 05/12/2014

Event Type  Other  

Event Description

Implant loss after minor trauma.

Manufacturer Narrative

Based on initial information (b)(4) 2014 the complaint was not considered mdr reportable.Upon receipt of additional information i.E.Implant loss (b)(6) 2014 the mdr decision was revised.Implant loss is known to occur, considered in the rmf and communicated in the ifu.There are no indications that the occured is a result of manufacturing or component failure.

• 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 3; SW SE-436 33
• Manufacturer Contact: carolina wessling ; ekonomivagen 2; askim 0000S-E-43 ; SW 0000SE-436 ; 17486175
• MDR Report Key: 3894222
• MDR Text Key: 20653830
• Report Number: 3007367732-2014-00025
• Device Sequence Number: 1
• Product Code: MAH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: Physician
• Type of Report: Initial
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2018
• Device Model Number: M51138
• Device Catalogue Number: M51138
• Device Lot Number: 131819
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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: 15 YR
• Patient Weight: 60