MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA OSV2, CATH.5CM, AVEC ANT; N/A

Catalog Number	909711
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that when the osv ii lumbar kit (909711) was opened, it was discovered that the guidewire was missing from the pack.The product was specifically ordered for the patient and the facility did not have another osvii kit available to use.The surgeon was able to insert the catheter ok (rare occurrence, usually need guidewire), and the shunt was implanted.No other issues occurred during the case.
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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The osv ii (lumbar) (909711) was returned for evaluation: device history record (dhr) - review of the history device records for the product code 909711 with lot 7302742 conformed to the specifications when released to stock.Failure analysis - the complaint is confirmed via the inspection.An image was taken of the ¿as received¿ kit, and the kit was visually inspected; the guidewire was missing from the kit.An awareness was conducted to the production team.Root cause - the issue reported by the customer is due to a packaging error.A query of our database was performed for lot 7302742.The query identified no additional complaints for the production lot., and a 12-month complaint review was performed for catalog # 909711 and complaint reason ¿missing components." the review identified no additional related complaints.As a result, no escalation action is required for the issue "missing components" as no trend is noted for the moment.An awareness session was conducted to the production team, and this issue will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: OSV2, CATH.5CM, AVEC ANT
• Common Device Name: N/A
• 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: 20860859
• Report Number: 3013886523-2024-00379
• Device Sequence Number: 3918452
• Product Code: JXG
• UDI-Device Identifier: 10381780034025
• UDI-Public: 10381780034025
• Combination Product (Y/N): N
• PMA/510(K) Number: K140722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 909711
• Device Lot Number: 7302742
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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
• Patient Age: 28 YR
• Patient Sex: Female