MAUDE Adverse Event Report: NOBEL BIOCARE AB REPLACE SELECT TAPERED PMC WP 5.0X16MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	37314
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user indicated the implant failed, however based on the available information the exact issue could not be identified.

• Brand Name: REPLACE SELECT TAPERED PMC WP 5.0X16MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• Manufacturer (Section G): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• Manufacturer Contact: gayco meel ; popeweg 72; venlo 5928 -SC ; NL 5928 SC ; 623202508
• MDR Report Key: 15339719
• Report Number: 9611993-2022-091046
• Device Sequence Number: 6438935
• Product Code: DZE
• UDI-Device Identifier: 07332747073355
• UDI-Public: (01)07332747073355(10)12031350(17)191018
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023113
• 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: Manufacturer
• Report Source: 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: 10/18/2019
• Device Model Number: 37314
• Device Catalogue Number: 37314
• Device Lot Number: 12031350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2014
• 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: 55 YR
• Patient Sex: Male