MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL SG VLV ONLY; CERTAS PLUS SMALL & RA W/SG

Catalog Number	828814PL
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/06/2025
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 facility reported a certas valve (id 828814pl) was implanted on (b)(6) 2020.On (b)(6) 2025, the valve was explanted, and the siphonguard had broken off from the valve mechanism.Patient was reported stable and recovering.
Additional Manufacturer Narrative
Updated fields: d4, d8, d9, g6, h1, h2, h3, h4, h6, h8, h11.The certas valve (id 828814pl) was returned for evaluation.Device history record (dhr) - review of the history device records for the valve, product code 82-8815pl with lot 4525168, conformed to specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 1.The valve was visually inspected; the siphon guard was torn and separated from the valve.The valve could not be leak tested, reflux tested, flush tested or siphon guard tested due to the damaged silicone housing.The valve passed the test for programming and pressure.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/tear resistance.
Event or Problem Description
N/a.

• Brand Name: CRTS SM IL SG VLV ONLY
• Common Device Name: CERTAS PLUS SMALL & RA 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: 23379904
• Report Number: 3013886523-2025-00288
• Device Sequence Number: 15669369
• Product Code: JXG
• UDI-Device Identifier: 10886704081944
• UDI-Public: (01)10886704081944(17)250131(10)4525168
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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 Expiration Date: 01/31/2025
• Device Catalogue Number: 828814PL
• Device Lot Number: 4525168
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2020
• 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 Age: 5 YR
• Patient Sex: Unknown