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

Model Number	M50318
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is possible that the abutment was not correctly aligned with the implant during abutment attachment and that the connection was damaged and later broke from this.But without the physical sample available we are unable to confirm this theory.
Event or Problem Description
Abutment loss.

• Brand Name: PONTO
• Common Device Name: BONE ANCHORED HEARING IMPLANT
• Manufacturer (Section D): OTICON MEDICAL AB; datavägen 37 b; askim, 43632 ; SW 43632
• Manufacturer (Section G): OTICON MEDICAL AB; datavägen 37 b; askim, 43632 ; SW 43632
• Manufacturer Contact: karl almén burman ; datavägen 37b; askim, 436 3-2 ; SW 436 32
• MDR Report Key: 13532239
• Report Number: 3007367732-2022-00003
• Device Sequence Number: 20120764
• Product Code: MAH
• UDI-Device Identifier: 05712149000425
• UDI-Public: 0105712149000425111903061724030610191098240M50318
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K152820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/15/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/06/2024
• Device Model Number: M50318
• Device Catalogue Number: M50318
• Device Lot Number: 191098
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown