FDA Adverse Event Injury Summary report: N

UNKNOWN IMPLANT

MDR report key: 12556440 · Received September 30, 2021

Report

Report Number
2027971-2021-115422
Event Type
Injury
Date Received
September 30, 2021
Date of Event
July 27, 2021
Report Date
September 30, 2021
Manufacturer
NOBEL BIOCARE AB
Product Code
DZE
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
SP
Reporter Occupation
DENTIST

Narratives

Description of Event or Problem · 1

IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE. (B)(4).USER:(B)(4) RECEIVED DATE OF THE RETURN PRODUCT:30/09/2021.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1451452 UNKNOWN IMPLANT ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention