FDA Adverse Event Injury Summary report: N

NOBELREPLACE CC PMC RP 4.3X10MM

MDR report key: 12002380 · Received June 15, 2021

Report

Report Number
2027971-2021-81094
Event Type
Injury
Date Received
June 15, 2021
Date of Event
May 26, 2021
Manufacturer
NOBEL BIOCARE USA INC
Product Code
DZE
UDI-DI
7332747073584
PMA / PMN Number
K073142
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CH
Reporter Occupation
DENTIST

Narratives

Description of Event or Problem · 1

PMN K073142, LST D109680, PROD CODE 76DZE, DEV 2027971.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
895144 NOBELREPLACE CC PMC RP 4.3X10MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE USA INC 13107137 7332747073584

Patients

Seq Age Sex Outcome Treatment
1 62 YR Required Intervention