Table 4:

Device/procedure/anesthesia–related adverse events during 2 years

No. of PatientsaKyphoplasty (n = 191)Vertebroplasty (n = 190)
With procedure/device/anesthesia-related (or possibly) AEs1211
    Blood and lymphatic disordersBone marrow edema01b
    Gastrointestinal disordersConstipation1c0
    Immune system disordersHypersensitivity01c
    Injury or procedural complicationsCement embolism1d1d
Implant site extravasation01e
Mental status changes postoperative01c
Procedural hypotension1c0
Procedural nausea/vomiting1c0
Procedural pain3f3f
Spinal fracture1g0
    Musculoskeletal disordersArthralgia1g0
Back pain2g3g
Muscle spasm1g0
Symptomatic vertebral fracture1g2g
    Psychiatric disordersHallucination1c0
    Respiratory disordersCOPD1c0
Respiratory failure01c
    Vascular disordersHematoma01h
  • Note:—COPD indicates chronic obstructive pulmonary disease.

  • a Patients may have had multiple AEs; all system organ class categories are listed when there was an event considered related (or possibly related) to device/procedure/anesthesia.

  • b In 1 patient, 1 event was considered nonserious and possibly related to bone cement.

  • c In 1 patient, 1 event was considered serious and related (or possibly related) to anesthesia and was resolved with medical intervention.

  • d In 1 patient, 1 event each was considered serious and bone cement–related (or possibly related). In each case, the event occurred after the surgical treatment of a subsequent fracture; the BKP event was resolved with oxygen, and the VP event was ongoing at final follow-up.

  • e In 1 patient, 1 event was considered bone cement–related and nonserious. A spinal canal leak was detected intraoperatively; CT was immediately performed without significant canal stenosis observed with no medical intervention given.

  • f Three patients in each group with 3 (2 serious) and 4 (all serious) events in the BKP and VP groups, respectively, were considered device-related (or possibly related) but were resolved.

  • g The number of patients reflected in the Table had events that were considered serious and related (or possibly related) to the device.

  • h In 1 patient, 1 event was nonserious and possibly related to the procedure (likely a prone position on the operating table).