MAUDE Adverse Event Report: OT MEDICAL GMBH OT-F1; OT-F1 IMPLANT, 3.8 X 8.0

Model Number	01-1381080000
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr was previously submitted to the fda by keystone dental.However, it was improperly submitted as a pdf file and we no longer have access to the webtrader account so we cannot confirm receipt by the fda.Therefore, out of an abundance of caution, we are resubmitting this mdr to the fda.
Event or Problem Description
Failed to osseo.

• Brand Name: OT-F1
• Common Device Name: OT-F1 IMPLANT, 3.8 X 8.0
• Manufacturer (Section D): OT MEDICAL GMBH; bremen, ; GM
• MDR Report Key: 9797968
• Report Number: 3005990499-2020-17215
• Device Sequence Number: 643593
• Product Code: DZE
• UDI-Device Identifier: EOTM0113810800001
• UDI-Public: +EOTM0113810800001/
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/24/2020

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: 01-1381080000
• Device Catalogue Number: 01-1381080000
• Device Lot Number: 26723/812271
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 03/06/2020
• 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: 44 YR