MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE WITH SIPHON 828804PL; INTERNAL CSF DRAINAGE

Catalog Number	828804PL
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Balance Problems (4401)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A physician reported a certas valve (id 828804pl) was implanted in (b)(6) 2024 at setting 3 due to hydrocephalus.The valve worked well until around (b)(6) 2025 when the patient began having issues like frequent falls.Clinicians changed setting to 2.The patient still had large ventricles and shunt study confirmed that fluid was not flowing properly through the valve.Manometer confirmed during revision surgery that valve was not working properly, therefore, the valve was explanted and replaced on (b)(6) 2026.
Additional Manufacturer Narrative
The certas valve, id (b)(6) was returned for evaluation.Failure analysis: the position of the cam when the valve was received was at setting 3.The valve was visually inspected; the siphon guard was slightly bent.One needle hole in the needle chamber.The valve passed the test for programming, occlusion, leak, reflux pressure test and siphon guard, root cause analysis: no root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the reported issue could be due to biologicals debris as noted in the ifu: "complications of implanted shunt systems include mechanical failure, shunt pathway obstruction, infection, foreign body (allergic) reaction to implants, and csf leakage along the implanted shunt pathway.".
Event or Problem Description
Na.

• 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 ; 6099362319
• MDR Report Key: 24469567
• Report Number: 3013886523-2026-00036
• Device Sequence Number: 13101579
• Product Code: JXG
• UDI-Device Identifier: 10381780521174
• UDI-Public: 10381780521174
• Combination Product (Y/N): N
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 828804PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female