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

Catalog Number	828804PL
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2025
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
2 of 3 reports (same product failure, different patients).Other mfg report numbers: 3013886523-2025-00100.3013886523-2025-00098.A facility reported a certas valve (id 828804pl) was implanted on (b)(6) 2021.On (b)(6) 2025, a magnetic resonance imaging (mri) revealed that the siphon guard had completely detached from body of valve, requiring revision surgery for explantation and replacement.The patient did not present signs and symptoms due to valve failure.Current status of the patient - no long-term damage.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The certas valve (id 828804pl) was returned for evaluation device history record (dhr) - the product code 82-8804pl with lot 5323909, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 4.The valve was visually inspected; the silicone housing around the siphon guard was cut/torn.The siphon guard was visually inspected marks were found on the siphon guard.The complaint is confirmed.Root cause analysis - 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.

• 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: 22010024
• Report Number: 3013886523-2025-00097
• Device Sequence Number: 7893748
• Product Code: JXG
• UDI-Device Identifier: 10381780521174
• UDI-Public: (01)10381780521174(17)260228(10)5323909
• Combination Product (Y/N): N
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 828804PL
• Device Lot Number: 5323909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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: 8 YR
• Patient Sex: Male
• Patient Weight: 29 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American