DIRECTINJECT 5CC
Received Oct 24, 2024 · Event occurred Oct 1, 2024
Report 0008010177-2024-00116 · MDR key 20529738
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Migration
- Adverse Event Without Identified Device or Use Problem
- Migration
Patient
NA · Female
- Pain
- Pain
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DUE TO A TRAUMA, FRAGMENTS OF THE IMPLANT (WHICH WAS INSERTED IN A PRIOR SURGERY) MIGRATED WITHIN THE PATIENT'S BODY.
Additional Manufacturer Narrative
DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT DUE TO A TRAUMA, FRAGMENTS OF THE IMPLANT (WHICH WAS INSERTED IN A PRIOR SURGERY) MIGRATED WITHIN THE PATIENT'S BODY.
Additional Manufacturer Narrative
THE REPORTED EVENT COULD NOT BE CONFIRMED, BECAUSE NO PICTURES OF THE REPORTED EVENT WERE PROVIDED. THE REPORTED EVENT WAS DISCUSSED WITH RELATED STAKEHOLDERS. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED ISSUES WERE NOT DETERMINED WITHIN THE INVESTIGATION. THEREFORE, NO PREVENTIVE AND/OR CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME.