FDA Adverse Event Injury Summary report: N

NOBELPARALLEL CC NP 3.75X8.5MM

MDR report key: 10870633 · Received November 19, 2020

Report

Report Number
2027971-2020-52004
Event Type
Injury
Date Received
November 19, 2020
Date of Event
November 9, 2020
Report Date
November 19, 2020
Manufacturer
NOBEL BIOCARE AB
Product Code
DZE
UDI-DI
7332747091434
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
SP
Reporter Occupation
DENTIST

Narratives

Description of Event or Problem · 0

IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATE. 24.11.2020 17:52:32 CET S. (B)(6). USER: (B)(6) RECEIVED DATE OF THE RETURN PRODUCT:17/11/2020.

Description of Event or Problem · 1

IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1332403 NOBELPARALLEL CC NP 3.75X8.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 12043539 7332747091434

Patients

Seq Age Sex Outcome Treatment
1 72 YR Life Threatening| R