FDA Adverse Event Injury Summary report: N

NOBELACTIVE INTERNAL RP 4.3X8.5MM

MDR report key: 10416416 · Received August 17, 2020

Report

Report Number
2027971-2020-27787
Event Type
Injury
Date Received
August 17, 2020
Date of Event
February 12, 2020
Report Date
August 17, 2020
Manufacturer
NOBEL BIOCARE AB
Product Code
DZE
UDI-DI
7332747017953
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
IN
Reporter Occupation
DENTIST

Narratives

Description of Event or Problem · 1

PMN K083205, LST D080128, PROD CODE 76DZE, DEV 9611993.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
877351 NOBELACTIVE INTERNAL RP 4.3X8.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 12113286 7332747017953

Patients

Seq Age Sex Outcome Treatment
1 51 YR Required Intervention