MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE VALVE ONLY

Catalog Number	828800PL
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/10/2025
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
Sales representative narrative: "the physician removed and revised shunt on (b)(6) 2025.He notified me on (b)(6) 2025, that the valve that he removed would not reprogram.He replaced the valve with a new certas valve.A different neurosurgeon implanted the valve a few years ago".
Additional Manufacturer Narrative
Updated fields: b3, e1, e3, g2, g3, g6, h2, h3, h11.Additional information received: did the patient had any signs and symptoms due to the product malfunction? if yes, please provide details.Answer: "no".Current status of the patient: answer: "good".
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 7.The valve was visually inspected, and no defect was noted.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 occlusions with the valve at the time of investigation.The possible root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the valve or to improper handling of the device, at the time of investigation no function issues were noted.

• Brand Name: CERTAS PLUS INLINE VALVE ONLY
• Common Device Name: CERTAS PLUS
• 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: 21264699
• Report Number: 3013886523-2025-00022
• Device Sequence Number: 9646694
• Product Code: JXG
• UDI-Device Identifier: 10381780521013
• UDI-Public: 10381780521013
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 828800PL
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 01/29/2025; 04/01/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/14/2025; 04/28/2025
• 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 Sex: Unknown