DECOMPRESSION OF CHOICE

Description of Event or Problem

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.