MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD DIRECT CLAMP ACTIVE ANCHOR KIT; SCS DIRECT CLAMP ACTIVE ANCHOR

Model Number	104523
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation of this event is in progress.Once the investigation is complete, a supplemental report will be submitted.
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system was evaluated for pain at the anchor implant site.A cortisone injection was administered to relieve the pain during healing.
Event or Problem Description
The patient¿s symptoms persisted despite receiving a pain injection.A revision procedure was completed on (b)(6) 2026, and the anchors were removed to resolve the reported event.
Additional Manufacturer Narrative
The anchors were not returned to saluda.A root cause for the reported implant pain could not be definitively determined but may have been related to the patient being thin.The evoke scs system surgical guide details potential risks associated with surgery and spinal cord stimulation including, "temporary or persistent post-surgical pain at hardware implantation sites and the patient may require surgery (including revision, explant, and replacement) as a result.¿.

• Brand Name: DIRECT CLAMP ACTIVE ANCHOR KIT
• Common Device Name: SCS DIRECT CLAMP ACTIVE ANCHOR
• Manufacturer (Section D): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw 2113 ; AU 2113
• Manufacturer (Section G): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw - ; AU -
• Manufacturer Contact: sadie mauser ; 5 eden park drive; macquarie park, nsw - ; AU -
• MDR Report Key: 24574304
• Report Number: 3021836309-2026-00072
• Device Sequence Number: 10355842
• Product Code: LGW
• UDI-Device Identifier: 09352307001817
• UDI-Public: 09352307001817
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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 Model Number: 104523
• Device Catalogue Number: 3043
• Device Lot Number: 9018812536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2025
• 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
• Patient Sex: Unknown