DIRECTINJECT 5CC
Received Oct 17, 2025 · Event occurred Sep 26, 2025
Report 0008010177-2025-00132 · MDR key 23322978
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: H6 THE REPORTED EVENT COULD NOT BE CONFIRMED, BECAUSE THE INFORMATION PROVIDED WAS NOT SUFFICIENT. THE INVESTIGATION FOUND NO EVIDENCE THAT THE DEVICE OR MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED EVENT; THE IMPLANT WAS STORED AND STERILIZED CORRECTLY, AND NO PATHOGENS WERE DETECTED IN CULTURES. THE SURGEON SUSPECTED INFECTION-LIKE SYMPTOMS WERE LINKED TO CEMENT SEPARATION AND SPREAD BEYOND THE INTENDED SITE, BUT THE PATIENT RECOVERED WITHOUT CONFIRMED INFECTION OR ADDITIONAL SURGERY. BASED ON THE INVESTIGATION, THERE IS NO INDICATION FOR AN INCORRECTLY WORKING PRODUCT OR ANY DESIGN, MATERIAL, OR MANUFACTURING-RELATED ISSUE. THEREFORE, NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME.
Description of Event or Problem
NO NEW INFORMATION.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT HAD A POSTOPERATIVE INFECTION.
Additional Manufacturer Narrative
DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.