FDA Adverse Event Injury Summary report: N

KLOCKNER DENTAL IMPLANTS

MDR report key: 540710 · Received August 19, 2004

Report

Report Number
9617542-2004-00002
Event Type
Injury
Date Received
August 19, 2004
Date of Event
April 19, 2004
Report Date
August 13, 2004
Manufacturer
SOADCO, S.L.
Product Code
DZE
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
SP
Reporter Occupation
NOT APPLICABLE

Narratives

Description of Event or Problem · 1

IMPLANT PLACED BETWEEN "MENTONIANS." REMOVAL OF THE IMPLANT DUE TO A SPRAIN CAUSED BY THE POOR PLACING OF THE MOVABLE PROSTHESIS BY THE PT. THE DENTURE WAS PLACED FIXED IN A SINGLE BALL JOINT, THIS WAS NOT NOTICED AND CAUSED THE LESION WHICH LED TO THE REPLACEMENT OF THE IMPLANT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 KLOCKNER DENTAL IMPLANTS DENTAL IMPLANT DZE SOADCO, S.L. 543710 *

Patients

Seq Age Sex Outcome Treatment
1 78 YR Other