MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL VLV ONLY; INTERNAL CSF DRAINAGE

Catalog Number	828810PL
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that a codman certas valve (id (b)(6)) was implanted on (b)(6) 2026.Valve initial setting not available.It was reported that the valve settings changed post-implantation.The settings were reset; however, they changed again.The most recent setting change was identified while the individual was at home.Valve settings were verified using a programming tool.No incident involving significant acceleration or deceleration (e.G., motor vehicle accident or fall) was reported.The valve was subsequently removed and replaced on (b)(6) 2026.The individual's condition was reported as stable and discharged home.
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: d6b, g3, g6, h2, h3, h11.Additional information received: please confirm explantation date: (b)(6) 2026.Did the patient experience any signs and symptoms due to valve setting changes? if yes, please explain - no such incident reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The certas valve (id (b)(6)) was returned for evaluation.Device history record (dhr) - the product code 82-8810pl with lot 6160769, conformed to the specifications when released to stock.Failure analysis - the position of the cam when the valve was received was at setting 4.The valve was visually inspected; a bump mark by cam was noted on the casing.The valve was program tested and failed.The valve is programmed but the rc remains in the upper position.The valve passed the test for occlusion, leak, reflux, siphon guard and pressure.The valve was observed under microscope: bump mark was observed on the casing.Root cause analysis - the root cause for the bump mark in the top of the casing is due to the valve receiving a hard knock.Following the shock, the rc is at the incorrect position (upper position) due to chock and the setting changes due to magnetic field, so according to ifu "the valve setting is adjusted with the application and manipulation of strong magnets.A change to the valve setting is unlikely to occur under normal circumstances.However, magnetic fields should not be placed near the valve due to the possibility of an unintentional setting change." the probable root cause for the issue reported by the customer is due to the valve receiving a hard knock.

• Brand Name: CRTS SM IL VLV 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: 24532761
• Report Number: 3013886523-2026-00048
• Device Sequence Number: 8895379
• Product Code: JXG
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: 828810PL
• Device Lot Number: 6160769
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 03/09/2026; 05/11/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/30/2026; 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2022
• 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
• Patient Weight: 35 LB
• Patient Race: Black Or African American