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

Catalog Number	828814PL
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
1 of 2 reports (same event/different products).Other mft report number: 3014334038-2026-00034 a physician reported a certas valve was placed on (b)(6) 2025.The physician experienced issues checking the valve setting and programming it with the electronic programmer.When attempting to adjust the valve, the electronic programmer appeared to be stuck between settings (2 and 3 or 3 and 4).On (b)(6) 2026, the physician attempted to adjust the valve to a setting of 4; however, when the valve was removed and the setting was checked, it was found to be set at 5.The issue may have been related to the certas valve or the electronic programmer used to confirm and change the setting.Out of caution and to address the patient¿s concern, the valve was removed and replaced on (b)(6) 2026.According to reporter: "the product number for the valve is either 828814pl or 828815pl.".
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
N/a.
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 4.The valve was visually inspected; no defect was noted.The valve was hydrated.The valve passed the test for programming, occlusion, leak, reflux, siphon guard and pressure.The valve functions.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 issue reported by the customer is due to biological debris and protein build up interfering with the valve, at the time of investigation, biological debris were found and as mentioned in the ifu: ¿accumulation of biological matter within the valve can: cause difficulties adjusting the valve setting with the tool kit¿.And/or the possible root cause could be due to user¿s error or an issue with the with the electronic programmer.

• 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: 25183279
• Report Number: 3013886523-2026-00116
• Device Sequence Number: 16137540
• Product Code: JXG
• UDI-Device Identifier: 10381780535942
• UDI-Public: 10381780535942
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: 828814PL
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 07/09/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ELECTRONIC PROGRAMMER; ELECTRONIC PROGRAMMER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown