MAUDE Adverse Event Report: Integra LifeSciences Switzerland SAR CERTAS PLUS INLINE WITH SIPHON 828804PL; Internal CSF Drainage

Catalog Number	828804PL
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Headache (1880); Memory Loss/Impairment (1958); Dizziness (2194)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a certas valve (b)(6) was implanted on (b)(6) 2023.The valve was fractured at the interface of the reservoir and anti-siphon.The patient was pumping the shunt valve at home, but no injury or fall reported.The patient was symptomatic from non-functioning shunt (headaches, dizziness, imbalance, and memory issues), and nuclear medicine (nm) scan showed shunt malfunction, therefore, the valve was explanted on (b)(6) 2026.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.Additional health effect-clinical code: e0101.

• Brand Name: CERTAS PLUS INLINE WITH SIPHON 828804PL
• Common Device Name: Internal CSF Drainage
• Manufacturer (Section D): Integra LifeSciences Switzerland SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): Integra LifeSciences Switzerland SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; +1(609)936-2319
• MDR Report Key: 50175250
• Report Number: 3013886523-2026-00191
• Device Sequence Number: 8270451
• Product Code: JXG
• UDI-Device Identifier: 10381780521174
• UDI-Public: (01)10381780521174(17)280229(10)7068197
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: 828804PL
• Device Lot Number: 7068197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 09/06/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 167 LB
• Patient Race: Asian