LYOPLANT ONLAY 10.0X12.5CM
Received Oct 12, 2017 · Event occurred Sep 15, 2017
Report 9610612-2017-00491 · MDR key 6944050
Device
Generic name
Lyoplant Onlay
Manufacturer
Aesculap AgModel number
1067050Catalog number
1067050
Lot number
216243
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. BASED ON THE DEVICE HISTORY REPORT AND QUALITY STANDARDS, WE CAN EXCLUDE A MANUFACTURING OR MATERIAL RELATED ERROR. NO CAUSALITY BETWEEN THE PRODUCT AND THE MENTIONED ISSUE CAN BE FOUND. A GRANULOMA OR SERUM CAN OCCUR, FOR EXAMPLE, CAUSED BY AN ISSUE MANIPULATION DURING SURGERY OR AN IMPROPER USER TECHNIQUE. AN INFECTION OF THE PATIENT THAT ALREADY EXISTED BEFORE SURGERY, CAN ALSO NOT BE EXCLUDED. NO CAPA IS NECESSARY.
Additional Manufacturer Narrative
EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING. DEVICE NOT RETURNED.
Description of Event or Problem
COUNTRY OF COUNTRY: USA. IT WAS REPORTD THAT AFTER A PATIENT HAD A GRADE I MENINGIOMA PROCEDURE, THE PATIENT HAD A RESECTION OF THE MENINGIOMA. LYOPLANT ONLAY WAS USED AT THE END OF THE SURGERY. MRI REVELED A GRANULOMA.