MAUDE Adverse Event Report: NOBEL BIOCARE AB REPLACE SELECT TAPERED PMC RP 4.3X16MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	37309
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Part fractured.

• Brand Name: REPLACE SELECT TAPERED PMC RP 4.3X16MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 19345279
• Report Number: 2027971-2024-080571
• Device Sequence Number: 12934873
• Product Code: DZE
• UDI-Device Identifier: 07332747160895
• UDI-Public: (01)07332747160895(10)12232451(17)281020
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section F): 05/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 37309
• Device Lot Number: 12232451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/08/2024
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2024
• 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: 75 YR
• Patient Sex: Male
• Date Report Sent to FDA: 05/17/2024