BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGITAL THERAPIST

    MDR report key: 25121475 · Received May 8, 2026

    Report

    Report Number
    3012900326-2026-00002
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    April 9, 2026
    Report Date
    April 27, 2026
    Manufacturer
    SWORD HEALTH S.A.
    Product Code
    ISD
    UDI-DI
    05065013876009
    PMA / PMN Number
    510(K)EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2026, THE MEMBER EXPRESSED CONCERN ABOUT A POSSIBLE RIB FRACTURE TO THE ASSIGNED PHYSICAL THERAPIST (PT) AFTER LOSING BALANCE DURING AN EXERCISE SESSION AND LANDING ON THE CORNER OF A TABLE. THE MANUFACTURER WAS MADE AWARE OF THIS INCIDENT ON 13-APR-2026. AT THE TIME OF THE REPORT, THE MEMBER HAD COMPLETED TWO THERAPY SESSIONS WITH THE DIGITAL THERAPIST (B)(6) 2026). THE MEMBER REPORTED ELEVATED PAIN LEVELS DURING BOTH SESSIONS. THE ASSIGNED PHYSICAL THERAPIST FOLLOWED UP AFTER EACH SESSION TO PROVIDE GUIDANCE AND ADJUST THE THERAPY PROGRAM BASED ON REPORTED SYMPTOMS. PRIOR TO STARTING THE PROGRAM, THE PHYSICAL THERAPIST ALSO REINFORCED THE RECOMMENDATION TO HOLD ONTO A STABLE OBJECT DURING STANDING EXERCISES AS A BALANCE-SUPPORT MEASURE. FOLLOWING THE REPORT OF THE INCIDENT, THE PHYSICAL THERAPIST REQUESTED ADDITIONAL DETAILS REGARDING THE EVENT AND INQUIRED WHETHER MEDICAL EVALUATION HAD BEEN SOUGHT. MULTIPLE FOLLOW-UP ATTEMPTS WERE MADE BY THE PHYSICAL THERAPIST VIA MESSAGING AND PHONE CALLS (INCLUDING ATTEMPTS ON (B)(6) 2026, WITH ADDITIONAL OUTREACH THROUGH (B)(6) 2026); HOWEVER, NO FURTHER RESPONSES WERE RECEIVED FROM THE MEMBER. AS OF THE DATE OF THIS REPORT, NO ADDITIONAL CLINICAL INFORMATION OR MEDICAL CONFIRMATION OF RIB FRACTURE HAS BEEN PROVIDED. THE MEMBER HAS A SIGNIFICANT MEDICAL HISTORY INCLUDING MULTIPLE PRIOR SPINAL SURGERIES, MOST RECENTLY UNDERGOING DISCECTOMY AND THORACIC SPINAL FUSION ON (B)(6) 2026. THE MEMBER WAS CLEARED BY THE SURGEON ON (B)(6) 2026 TO BEGIN LIGHT TO MODERATE PHYSICAL THERAPY WITH A REPORTED LIFTING RESTRICTION OF 25 LBS. THE MEMBER REPORTS VARIABLE PAIN LEVELS (2/10 TO 8/10) EXACERBATED BY PROLONGED STANDING AND WALKING, AS WELL AS PERSISTENT RIGHT LOWER EXTREMITY WEAKNESS REQUIRING THE USE OF ASSISTIVE DEVICES (ROLLATOR AT HOME AND FOREARM CRUTCHES FOR TRANSFERS). THE MEMBER ALSO REPORTED A FALL APPROXIMATELY ONE WEEK POST-SURGERY WITH ONGOING KNEE PAIN. MEDICATION INCLUDES HYDROCODONE FOR PAIN MANAGEMENT. NO RECENT UNEXPLAINED LOSS OF STRENGTH, SENSATION, OR BOWEL/BLADDER DYSFUNCTION WAS REPORTED. FUNCTIONAL ASSESSMENT INDICATES LIMITED MOBILITY, INCLUDING DIFFICULTY WITH TRANSFERS AND AMBULATION, AND ALTERED GAIT MECHANICS. THE MANUFACTURER CONDUCTED AN INVESTIGATION THAT INCLUDED REVIEW OF THE MEMBER'S REPORTED INFORMATION, PHYSICAL THERAPIST DOCUMENTATION, DEVICE USAGE DATA, AND INPUT FROM THE ALGORITHMS TEAM. DURING THE SESSION ON (B)(6) 2026, THE MEMBER FLAGGED MULTIPLE EXERCISES AS PHYSICALLY CHALLENGING, BEGINNING WITH HIP HYPEREXTENSION, FOLLOWED BY TRUNK ROTATION, SINGLE LEG STANCE, AND SIDESTEP EXERCISES. THE SIDESTEP EXERCISE WAS THE LAST PERFORMED IN THAT SESSION, WITH NO CORRECT MOVEMENTS RECORDED. DURING THE INITIAL SESSION ON (B)(6) 2026, NO EXERCISES WERE FLAGGED BY THE MEMBER. REVIEW OF SYSTEM METRICS DID NOT IDENTIFY ANY DEVICE MALFUNCTION OR TECHNICAL ISSUE. THE ALGORITHMS TEAM CONFIRMED THAT FRAMING METRICS WERE WITHIN ACCEPTABLE PARAMETERS AND THAT LIGHTING CONDITIONS WERE UNLIKELY TO HAVE SIGNIFICANTLY IMPACTED PERFORMANCE, ALTHOUGH MASK LUMINANCE MAY HAVE BEEN SUBOPTIMAL. ANALYSIS OF AVATAR DATA FROM THE INITIAL SESSION INDICATED LIMITED HIP MOBILITY, WHICH MAY CONTRIBUTE TO DIFFICULTY WITH BALANCE DURING SOME EXERCISES. AVATAR ANALYSIS FOR THE (B)(6) 2026 SESSION COULD NOT BE PERFORMED BECAUSE THE SESSION HAD NOT SYNCHRONIZED; SYNCHRONIZATION REQUIRES THE DEVICE TO BE POWERED ON, AND NO FURTHER ACTION WAS POSSIBLE DUE TO LACK OF RESPONSE FROM THE MEMBER. BASED ON THE AVAILABLE INFORMATION, NO DEVICE MALFUNCTION OR PERFORMANCE ISSUE WAS IDENTIFIED. THE MEMBER DID NOT REPORT ANY TECHNICAL ISSUES WITH THE DEVICE. THE REPORTED LOSS OF BALANCE OCCURRED DURING PERFORMANCE OF A DIGITAL THERAPIST-GUIDED EXERCISE. BASED ON THE AVAILABLE INFORMATION, A CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED INJURY COULD NOT BE ESTABLISHED. AT THIS TIME, THE REPORTED RIB FRACTURE REMAINS MEDICALLY UNCONFIRMED.

    Description of Event or Problem · 0

    ON (B)(6) 2026, THE MEMBER EXPRESSED CONCERN ABOUT A POSSIBLE RIB FRACTURE TO THE ASSIGNED PHYSICAL THERAPIST (PT) AFTER LOSING BALANCE DURING AN EXERCISE SESSION AND LANDING ON THE CORNER OF A TABLE. AT THE TIME OF THE REPORT, THE MEMBER HAD COMPLETED TWO THERAPY SESSIONS WITH THE DIGITAL THERAPIST (B)(6) 2026). THE MEMBER REPORTED ELEVATED PAIN LEVELS DURING BOTH SESSIONS. THE ASSIGNED PHYSICAL THERAPIST FOLLOWED UP AFTER EACH SESSION TO PROVIDE GUIDANCE AND ADJUST THE THERAPY PROGRAM BASED ON REPORTED SYMPTOMS. PRIOR TO STARTING THE PROGRAM, THE PHYSICAL THERAPIST ALSO REINFORCED THE RECOMMENDATION TO HOLD ONTO A STABLE OBJECT DURING STANDING EXERCISES AS A BALANCE-SUPPORT MEASURE. FOLLOWING THE REPORT OF THE INCIDENT, THE PHYSICAL THERAPIST REQUESTED ADDITIONAL DETAILS REGARDING THE EVENT AND INQUIRED WHETHER MEDICAL EVALUATION HAD BEEN SOUGHT. NO FURTHER INFORMATION OR MEDICAL CONFIRMATION OF RIB FRACTURE HAS BEEN RECEIVED FROM THE MEMBER DESPITE MULTIPLE FOLLOW-UP ATTEMPTS VIA MESSAGING AND PHONE CALLS THROUGH (B)(6) 2026. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT INVOLVED LOSS OF BALANCE DURING EXERCISE PERFORMANCE. NO DEVICE MALFUNCTION OR TECHNICAL ISSUE WAS IDENTIFIED OR REPORTED BY THE MEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423086 DIGITAL THERAPIST Exerciser, measuring ISD SWORD HEALTH S.A. 05065013876009

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention