MAUDE Adverse Event Report: PIVOTAL HEALTH SOLUTIONS, INC Decompression of Choice; DOC

Model Number	E9011
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Neck Pain (2433); Insufficient Information (4580)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient complained of sprained neck after receiving cervical decompression treatment.
Additional Manufacturer Narrative
Manufacturer's narrative: on , 6/23/2026 the manufacturer received a report, regarding an incident involving our spinal decompression device.The clinic reported that during a decompression therapy session, the device "pulled too far," resulting in the patient sustaining a sprained neck.The event was described as a serious injury.The device is a non-invasive spinal decompression system designed to apply controlled traction.No specific device malfunction was confirmed at the time of the initial report.The clinic indicated that the treatment parameters or patient positioning may have contributed, but further details were not immediately available.Investigation status: the manufacturer has initiated a formal investigation per our mdr procedures and quality system (21 cfr part 820).We have requested additional information from the clinic, including: detailed event circumstances (e.G., treatment settings, patient positioning, operator observations).Patient medical history relevant to the event.Device identification details (model, serial/lot number, service/maintenance history).Availability of the device for return and evaluation or on-site review.Any photos, usage logs, or witness statements.We have also asked the clinic to perform basic testing/evaluation of the device as returned (or in situ) to assess for any potential mechanical or control issues.As of the date of this report, the clinic has not yet completed the requested testing or provided the full details.We continue to follow up actively.No similar incidents have been identified in our complaint history for this device model to date.A root cause analysis is ongoing to determine whether the event resulted from a device malfunction, user error, patient factors, or a combination.Possible contributing factors under consideration include operator technique, patient-specific anatomy/conditions, or software/hardware performance outside expected parameters.This report is being submitted within the 30-day window to meet fda mdr requirements (21 cfr part 803) while our investigation remains open.A supplemental report will be submitted promptly upon receipt of additional information, completion of device evaluation, and/or final determination of root cause.If the investigation identifies a reportable malfunction or confirms causation/contribution by the device, appropriate corrective actions will be implemented.

• Brand Name: Decompression of Choice
• Common Device Name: DOC
• Manufacturer (Section D): PIVOTAL HEALTH SOLUTIONS, INC; 3003 9th ave. sw; watertown SD 57201
• Manufacturer (Section G): Pivotal Health Solutions, Inc.; 3003 9th ave sw; watertown SD 57201
• Manufacturer Contact: jeremy kincade ; 3003 9th ave sw; watertown, SD 57201
• MDR Report Key: 25832018
• Report Number: 3007278668-2026-00005
• Device Sequence Number: 18737821
• Product Code: ITH
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K101889
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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 Model Number: E9011
• Was Device Available for Evaluation?: Yes
• 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: 06/23/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown