InjuryHBW
RESORB XG
Received Oct 13, 2023
Report 9610905-2023-00052 · MDR key 17934332
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
12 MO · Female
- Impaired Healing
- Impaired Healing
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION WAS SUCCESSFULLY COMPLETED. THE RESULTS OF THE INVESTIGATION HAVE IDENTIFIED NO MANUFACTURING ISSUES, NO DESIGN ISSUES AND/OR CORRECTIVE ACTIONS NECESSARY AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED. CORRECTIONS: D3 - COMPANY NAME CHANGE ONLY. G1 - COMPANY ESTABLISHMENT NAME UPDATED ONLY - TYPO. G1 - CONTACT OFFICE - MANUFACTURING SITE NAME/ADDRESS TYPO.
Description of Event or Problem
IT WAS REPORTED THAT RESORBABLE MESH BECAME BENT IN CRANIAL REMODELING CASE. IT WAS REMOVED.