FDA Adverse Event Injury Summary report: N

INTERPORE IMZ IMPLANT

MDR report key: 83356 · Received April 9, 1997

Report

Report Number
2029012-1997-00081
Event Type
Injury
Date Received
April 9, 1997
Date of Event
February 25, 1997
Report Date
April 9, 1997
Manufacturer
INTERPORE INTL.
Product Code
DZE
Removal / Correction Number
NA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
MO, US
Reporter Occupation
DENTIST

Narratives

Description of Event or Problem · 1

DENTAL IMPLANT WAS EXPLANTED DUE TO INADEQUATE OSTEOINTEGRATIONL. THE PT DEVELOPED EXUDATE 2-3 MONTHS POST-IMPLANTATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 INTERPORE IMZ IMPLANT Implant ENDOSSEOUS DENTAL IMPLANT DZE INTERPORE INTL. NA 608001

Patients

Seq Age Sex Outcome Treatment
1 57 YR Required Intervention