MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SML SGA VLV; INTERNAL CSF DRAINAGE

Catalog Number	828814PL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a certas valve (id: 828814pl) broke into two pieces upon insertion and was identified as defective at the time of implantation.The defective valve was explanted and replaced with a new valve during the same surgical procedure on (b)(6) 2025.The patient did not experience any signs or symptoms related to product problem.The patient¿s current status is stable.
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, h4, h6, h11.The certas valve (id 828814pl) was returned for evaluation.Device history record (dhr) - the product code 82-8814pl with lot 7478098, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 3.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 and tear resistance."do not fold or bend the valve during insertion.Folding or bending might cause rupture of the silicone housing, needle guard dislodgement, or occlusion of the fluid pathway.".
Event or Problem Description
N/a.

• Brand Name: CRTS SML SGA VLV
• 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: 24034551
• Report Number: 3013886523-2026-00002
• Device Sequence Number: 9140314
• Product Code: JXG
• UDI-Device Identifier: 10381780535942
• UDI-Public: (01)10381780535942(11)241105(17)291031(10)7478098
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 828814PL
• Device Lot Number: 7478098
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 44 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American