MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE WITH SIPHON; CERTAS PLUS W/ SG

Catalog Number	828804PL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Feeding Problem (1850); Vomiting (2144)
Date of Event	10/17/2025
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 physician assistant reported a certas valve (id 828804pl) was implanted on (b)(6) 2025, due to hydrocephalus.The patient was brought to the emergency department (ed) after showing symptoms of shunt failure (vomiting, unable to eat and head size).The shunt was discovered to be broken after imaging, therefore the valve was removed and replaced on (b)(6) 2025, and all broken parted were recovered.The patient condition is stable.
Additional Manufacturer Narrative
Updated fields: d4, d8, d9, g6, h1, h2, h3, h6, h11.The certas valve (828804pl) was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 4.The valve was visually inspected; the siphon guard was torn and separated from the valve.The valve passed the test for programming and pressure.The valve could not be leak tested, reflux tested, flush tested or siphon guard tested due to the damaged silicone housing.The siphon guard was visually inspected marks were found on the siphon guard.Root cause -the possible root cause for the issue reported by the customer, is due to a sharp or pointed object coming into contact with the valve in view of the cut marks on housing.As noted in the surgical procedure precautions section in ifu, silicone has a low cut/tear resistance.
Event or Problem Description
N/a.

• Brand Name: CERTAS PLUS INLINE WITH SIPHON
• Common Device Name: CERTAS PLUS W/ SG
• 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: 23498361
• Report Number: 3013886523-2025-00293
• Device Sequence Number: 15661065
• 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 Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 12/25/2025

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: 10/20/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/25/2025
• 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 Age: 12 MO
• Patient Sex: Female