MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE WITH SIPHON; CERTAS PLUS W/ SG

Catalog Number	828804PL
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/17/2025
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
A physician reported a certas valve (id 828804pl) was implanted in (b)(6) 2023.During an hospital admission on 2025, the physician attempted to change the patient¿s shunt from 5 to 7 and was unable to program and adjust it, tried multiple programmers and valve would not move.Multiple providers attempted to change the setting, including using a stronger magnet, without success, therefore, the valve was removed and replaced on (b)(6) 2025.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The certas valve (id 828804pl) was returned for evaluation.Device history record: the product code 82-8804pl with lot 7266810, conformed to the specifications when released to stock.Failure analysis: the position of the cam when valve was received was at setting 7.The valve was visually inspected; debris and blood were noted inside and outside the housing.The valve passed the test for occlusion, leak, siphon guard and reflux.The valve failed the test for programming and pressure.The valve was disassembled and was visually inspected under microscope at appropriate magnification; biological debris were found on the rotating construct and housing.Root cause analysis: the root cause for the programming issue reported by the 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".The root cause for the pressure issue noted during the investigation is due to biological debris found on the ruby ball, the debris was stopping the ruby ball from being seated correctly.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h10, h11.Additional information: related report number (h10) - mw5178161.
Event or Problem Description
N/a.

• Brand Name: CERTAS PLUS INLINE WITH SIPHON
• Common Device Name: CERTAS PLUS W/ SG
• 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: 23728863
• Report Number: 3013886523-2025-00309
• Device Sequence Number: 16110065
• Product Code: JXG
• UDI-Device Identifier: 10381780521174
• UDI-Public: (01)10381780521174(17)280630(10)7266810
• Combination Product (Y/N): N
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2026

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: 828804PL
• Device Lot Number: 7266810
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 01/05/2026; 03/02/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/21/2026; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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