MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTSÂ SMÂ ILÂ VLVÂ ONLY; INTERNAL CSF DRAINAGE

Catalog Number	828810PL
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a certas valve (id 828810pl) would not change pressure level settings from 5 despite numerous attempts.Therefore, the valve was removed.No additional information was provided after several attempts.
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 Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The certas valve (id 828810pl) was returned for evaluation.Failure analysis: the position of the cam when valve was received was at setting 5.The valve was visually inspected, rc in up position.The valve was irrigated and hydrated.The valve failed the test, rc in up position.The valve passed the test for occlusion, leak and reflux.The valve failed the pressure test.The valve was observed under microscope: knock marks were observed on the casing.The decontamination method used on the device, eto, is not the recommended one for this product, but it didn't have an impact on the product.Root cause analysis: the root cause for programming issues reported by the customer and observed during investigation is due to rotation construction being stuck in up position.The root cause for pressure issue during investigation is due to rotation construction being stuck in up position.The root cause for the rotation construction being stuck in up position was due to the valve receiving a hard knock.
Event or Problem Description
Na.

• Brand Name: CRTSÂ SMÂ ILÂ VLVÂ ONLY
• 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: 23988178
• Report Number: 3013886523-2025-00344
• Device Sequence Number: 4554493
• Product Code: JXG
• UDI-Device Identifier: 10381780529316
• UDI-Public: 10381780529316
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 828810PL
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/13/2026
• 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 Age: 8 YR
• Patient Sex: Female