MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA OSV II (LUMBAR); INTERNAL CSF DRAINAGE

Catalog Number	909711
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	Headache (1880)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that the patient was experiencing headaches and the surgeon thought that it may be due to under draining of the osv ii lumbar valve (909711).The valve was removed and another implanted.The initial implantation date has not been reported, and it is unknown which valve was implanted during revision surgery.Patient is male with complicated inph.Additional information received as follows: "his last osv revision was (b)(6).Well until august.Then gradually increasing low pressure symptoms, partially managed by going up on vp shunt setting & asd until reaching max settings there (20mm main valve & 40mm asd).The patient also has a vp shunt in (so vp and lp with our osv being the lp shunt) and has quite complex management needs.".
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
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11 the osv ii lumbar valve (909711) was returned for evaluation: failure analysis - the complaint is confirmed via the inspection.The device was not returned with the packaging, and the lot number was not reported so the device history record (dhr) could not be reviewed.Images were taken of the ¿as received¿ device, the valve was visually inspected, and no defect was noted.The returned product was not decontaminated; therefore, the valve was internally decontaminated with steam which has no impact on this defect.It was observed that the curve is typical of the "blocked/occluded" defect, and air permeability tests done on the valve had failed results.Root cause - 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 as noted on the ifu: ¿major complications include mechanical failure, such as tubing fracture, material deterioration with time, or shunt pathway obstruction, infection, immune system reaction to materials and csf leakage along the shunt pathway.System disconnection can lead to catheter migration into the atrium, peritoneum or lateral ventricles.Ventricular shunting has been associated with epilepsy, and shunt dependency.Intracranial hypertension syndrome is a specific result of obstruction.¿ no corrective action has been initiated for the same or similar issue.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: OSV II (LUMBAR)
• Common Device Name: INTERNAL CSF DRAINAGE
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer (Section G): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 23796597
• Report Number: 3013886523-2025-00322
• Device Sequence Number: 18759732
• Product Code: JXG
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: 909711
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 05/01/2026
• 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: Other
• Patient Sex: Male