MAUDE Adverse Event Report: OT MEDICAL GMBH OT - F1; 3,8 X 12 TPS

Model Number	01-1381120000
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr was previously submitted to the fda by keystone dental.
Event or Problem Description
Implant loss.

• Brand Name: OT - F1
• Common Device Name: 3,8 X 12 TPS
• Manufacturer (Section D): OT MEDICAL GMBH; bremen, ; GM
• MDR Report Key: 9786876
• Report Number: 3005990499-2020-15709
• Device Sequence Number: 11229130
• Product Code: DZE
• UDI-Device Identifier: EOTM0113811200001
• UDI-Public: +EOTM0113811200001/$$323053126221810407F
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/27/2020

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: Health Professional
• Device Model Number: 01-1381120000
• Device Catalogue Number: 01-1381120000
• Device Lot Number: 26221/810407
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 70 YR