MAUDE Adverse Event Report: REPLACE SELECT TAPERED PMC 6.0 6X11.5MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	37317
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to a loss of osseointegration.

• Brand Name: REPLACE SELECT TAPERED PMC 6.0 6X11.5MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• MDR Report Key: 12748130
• Report Number: 9611993-2021-103389
• Device Sequence Number: 4489663
• Product Code: DZE
• UDI-Device Identifier: 07332747073324
• UDI-Public: (01)07332747073324(10)12111697(17)230428
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K023113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial

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 Expiration Date: 04/28/2023
• Device Model Number: 37317
• Device Catalogue Number: 37317
• Device Lot Number: 12111697
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2018
• 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 Age: 65 YR