NOBELPARALLEL CC NP 3.75X10MM
Received Jun 26, 2019 · Event occurred May 27, 2019
Report 9611993-2019-00001 · MDR key 8735172
Device
Generic name
Endosseous Dental Implant
Manufacturer
Nobel Biocare Ab, ProduktionModel number
37965Catalog number
37965
Lot number
12129104
Product problems
- Inaccurate Information
- Inaccurate Information
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
INTERNAL REFERENCE NUMBER: (B)(4).
Description of Event or Problem
ISSUE DESCRIPTION: A CUSTOMER IN (B)(6) INFORMED NOBEL BIOCARE ON (B)(6) 2019 THAT A PRODUCT (ART. #37965; BATCH. # 12129104) WAS LABELED 3.75X7MM ON THE CAP WHILE THE LABEL ON THE TUBE INDICATED 3.75X10MM. THE CORRECT SIZE ON THE LABEL FOR THIS ARTICLE IS 3.75X10MM. THE IMPLANT WAS RETURNED TO NOBEL BIOCARE UNOPENED. MANUFACTURER INVESTIGATION: A RETAIN SAMPLE WAS PERFORMED ON JUNE 03,2019 TO CONFIRM THAT THE ARTICLES WERE CORRECTLY LABELLED. THE RETAIN SAMPLES COMPLIED WITH SPECIFICATION. ARTICLES FROM THE BATCH STILL IN STOCK WERE CHECKED, NO OTHER LABELLING ISSUES WERE DISCOVERED. NO OTHER COMPLAINTS WERE RECEIVED REGARDING THE SAME BATCH.