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

Catalog Number	828804PL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	03/07/2024
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
1 of 2 reports.Other mfg report number: 3013886523-2024-00091 a facility reported an eleven year-old patient with an extensive medical and surgical history presented with new syrinx, underwent a redo chiari and since they thought he was over shunting from his certas (unknown id-without siphonguard), they decided to transition him to a siphonguard on (b)(6) 2024 ((b)(6)).The patient then presented on (b)(6) 2024, with a subgaleal fluid collection and a broken valve.When they exchanged him to a new valve, they drilled a trough for the valve in his calvarium, so now the valve sits in a wall of bone.He is nonverbal autistic and does have self-hitting behavior.They are not sure if he broke his valve.The broken valve was removed and replaced on (b)(6) 2024, with another new (b)(6).
Additional Manufacturer Narrative
The certas valve (id 828804pl) was returned for evaluation.Device history record (dhr) - the product code 82-8804pl with lot 7242876, 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, the valve dirty by the biological debris.The siphon guard was damaged, a cut mark was noted on the siphon guard.The valve was hydrated.The valve passed the test for programming and pressure.The flush, leak, reflux and siphon guard tests could not be performed as the siphon guard was damaged.Root cause analysis - the root cause for the issue reported by the customer is due a sharp or pointed object coming into contact with the valve or atypical handling, as noted in the surgical procedure precautions section in instruction for use (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 ; 6099362319
• MDR Report Key: 18966525
• Report Number: 3013886523-2024-00089
• Device Sequence Number: 6571368
• Product Code: JXG
• UDI-Device Identifier: 10381780521174
• UDI-Public: (01)10381780521174(17)280430(10)7242876
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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: 7242876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Age: 11 YR
• Patient Sex: Unknown