BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARFORMER

    MDR report key: 24283091 · Received February 6, 2026

    Report

    Report Number
    9613462-2026-00001
    Event Type
    Injury
    Date Received
    February 6, 2026
    Report Date
    March 24, 2026
    Manufacturer
    FOTONA D.O.O.
    Product Code
    QPL
    PMA / PMN Number
    K241785
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON ADDITIONAL DATA RECEIVED FROM THE TREATING FACILITY, INCLUDING PATIENT MEDICAL HISTORY AND PERFORMED TREATMENT TIMELINE, A CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED INJURY CANNOT BE ESTABLISHED. OSTEOPOROSIS, OSTEOPENIA, OR A PRE-EXISTING VERTEBRAL INJURY, THAT COULD IN A WORST-CASE SCENARIO POTENTIALLY ACT AS A PRECIPITATING FACTOR FOR A COMPRESSION FRACTURE, WAS EXCLUDED. ADDITIONALLY, PATIENT HISTORY REVEALED A COMPLICATED MEDICAL BACKGROUND INCLUDING A FALL FROM A HORSE PRIOR TO STARFORMER TREATMENT, SUGGESTING OTHER FACTORS MORE LIKELY CONTRIBUTED TO THE REPORTED CLINICAL OUTCOME.

    Additional Manufacturer Narrative · 0

    AS OF TODAY, NO DIAGNOSTIC REPORTS (MRI OR OTHER IMAGING) HAVE BEEN MADE AVAILABLE FOR THE INVESTIGATION. INFORMATION REGARDING THE PATIENT'S RELEVANT MEDICAL HISTORY IS ALSO STILL PENDING. TWO INDEPENDENT PHYSICIANS HAVE STATED THAT THE EVENT IS UNLIKELY TO BE RELATED TO THE TREATMENT, AS THERE IS NO DOCUMENTED EVIDENCE LINKING MAGNETIC STIMULATION-INDUCED SUPRAMAXIMAL MUSCLE CONTRACTIONS TO VERTEBRAL COMPRESSION FRACTURES. BASED ON THEIR ASSESSMENT, HIGH-INTENSITY MAGNETIC MUSCLE STIMULATION ALONE IS UNLIKELY TO CAUSE AN ACUTE THORACIC VERTEBRAL COMPRESSION FRACTURE IN A STRUCTURALLY NORMAL SPINE. HOWEVER, ACCORDING TO THE OPINION OF ONE PHYSICIAN, IN PATIENTS WITH OSTEOPOROSIS, OSTEOPENIA, OR PRE-EXISTING VERTEBRAL PATHOLOGY, SUCH MUSCLE CONTRACTIONS COULD PLAUSIBLY ACT AS A PRECIPITATING FACTOR. SHOULD NO PRIOR DIAGNOSTIC EVALUATION BECOME AVAILABLE, FURTHER ASSESSMENT WAS RECOMMENDED, INCLUDING EVALUATION OF BONE MINERAL DENSITY AND FRACTURE RISK FACTORS, TO ASSESS THE PLAUSIBILITY OF THIS SCENARIO.

    Description of Event or Problem · 0

    A PATIENT CLAIMS BACK INJURY WITH COMPRESSION FRACTURE AT T8 AND A HERNIATED DISC AFTER TREATMENT WITH STARFORMER.

    Description of Event or Problem · 0

    A PATIENT CLAIMS BACK INJURY WITH COMPRESSION FRACTURE AT T8 AND A HERNIATED DISC AFTER TREATMENT WITH STARFORMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96493 STARFORMER STARFORMER QPL FOTONA D.O.O.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other