MAUDE Adverse Event Report: PAJUNK GmbH Medizintechnologie SonoPlex II Facet; SonoPlex II Facet_NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number	001285-74
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury

• Brand Name: SonoPlex II Facet
• Common Device Name: SonoPlex II Facet_NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): PAJUNK GmbH Medizintechnologie; karl-hall-str. 1; geisingen, baden-württemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GmbH Medizintechnologie; karl-hall-str. 1; geisingen, baden-württemberg 78187 ; GM 78187
• Manufacturer Contact: armin pfeifer ; karl-hall-str. 1; geisingen, baden-württemberg 78187 ; GM 78187
• MDR Report Key: 50564542
• Report Number: 9611612-2026-00021
• Device Sequence Number: 13250718
• Product Code: BSP
• UDI-Device Identifier: 04048223131008
• UDI-Public: 04048223131008
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K243682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 001285-74
• Device Lot Number: 1627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown