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

Catalog Number	828804PL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/05/2025
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 facility reported a certas valve (id 828800pl) was implanted via ventriculoperitoneal (vp) shunt on an unknown date.The surgeon said the valve failed and had to be explanted.O additional information has been provided after several attempts.
Additional Manufacturer Narrative
Updated fields: short description, d1, d2a, d4, d9, g3, g6, h2, h3, h6, h11.The certas valve (id 828804pl) was returned for evaluation.Failure analysis: the position of the cam when valve was received was at setting 2.The valve was visually inspected; needle guard was raised.The valve failed the programming, occlusion, leak and pressure.The valve passed the reflux and siphonguard.The valve was dismantled and observed under microscope: tear noted on the needle chamber.Biologicals debris were noted on the cb arm, ruby ball and seat, and on the motor.Root cause analysis: the root cause for the raised needle guard noted during the investigation could be due to handling, as noted in the ifu.Do not fold or bend the valve, folding or bending might cause rupture of the silicone housing, needle guard disc dislodgement or occlusion of the fluid pathway.The root cause for the leakage issue is due to a cut/tear in the silicone housing of the needle chamber.The root cause for the programming and pressure issue is due to biologicals debris noted during investigation.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.Clinical signs such as headache, irritability, vomiting, drowsiness, or mental deterioration might be signs of a nonfunctioning shunt.
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: 23892432
• Report Number: 3013886523-2025-00336
• Device Sequence Number: 4451250
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/25/2025
• Supplement Report FDA Received Date: 02/27/2026
• 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: Unknown