MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG REPLACE SELECT TAPERED PMC RP 4.3X11.5MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	37307
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Abscess (1690); Failure of Implant (1924)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration.

• Brand Name: REPLACE SELECT TAPERED PMC RP 4.3X11.5MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB GÖTEBORG; bohusgatan 15; göteborg 41139 ; SW 41139
• MDR Report Key: 20690397
• Report Number: 2027971-2024-142529
• Device Sequence Number: 20653450
• Product Code: DZE
• UDI-Device Identifier: 07332747073423
• UDI-Public: (01)07332747073423(10)13059812(17)230115
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section F): 11/14/2024

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: 01/15/2023
• Device Catalogue Number: 37307
• Device Lot Number: 13059812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/07/2024
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Date Report Sent to FDA: 11/14/2024