KYPHON Express Osteo Introducer System T34ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000025755), received between Nov 24, 2019 and Oct 19, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2022Break; Break

  INFORMATION WAS RECEIVED FROM THE REGULATORY BODY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A KYPHOPLASTY PROCEDURE. IT WAS REPORTED THAT DURING THE KYPHOPLASTY THE BALLOON WAS INFLATED TO OPEN THE SPACE PRIOR TO INJECTING CEMENT. WHEN THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON TO REMOVE IT AND INJECT THE CEMENT, THE BALLOON WAS CAUGHT ON THE VERTEBRAL BODY AND WAS TORN DURING THE ATTEMPT TO DISLODGE. THE PHYSICIAN THEN REMOVED THE SUPPLIES. OPENING A NEW PROCEDURE PACK HE BEGAN THE PROCEDURE AGAIN. APPROACHING FROM THE RIGHT SIDE OF THE SPINE. THE SECOND ATTEMPT WAS SUCCESSFUL AND THERE WERE NO FURTHER COMPLICATIONS. IT WAS DETERMINED THAT THE FRAGMENT OF BALLOON LEFT IN THE SPACE WOULD NOT CAUSE ANY HARM TO THE PATIENT AND ANY FURTHER ATTEMPTS TO RETRIEVE IT WOULD POTENTIALLY CAUSE DAMAGE. A 10-GAUGE CANNULA WAS INTRODUCED INTO THE LEFT SIDE OF THE L4 VERTEBRAL BODY USING A UNIPEDICULAR APPROACH. A SECOND 10-GAUGE INTRODUCER NEEDLE WAS INTRODUCED INTO THE RIGHT L4 PEDICLE. A BALLOON CATHETER WAS INTRO DUCED THROUGH THE LEFT SIDED CANNULA AND INFLATED UNDER FLUOROSCOPIC GUIDANCE. WHEN IT CAME TIME TO WITHDRAW THE BALLOON, THE BALLOON BECAME STU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629990 ↗
• InjuryJul 31, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH UNKNOWN INDICATION FOR SPINAL THERAPY. IT WAS REPORTED THAT BROKEN PIECE OF PRODUCT REMAINED IN BONE. PRODUCT WILL BE RETURNED. IT IS STILL UNKNOWN THAT HOW THE DEVICE BROKE. THERE WERE NOT FURTHER COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10349475 ↗
• InjuryNov 24, 2019Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SACROPLASTY AT SACRUM AND ILIAC REGION. THE PATIENT HAD A VERY DENSE BONE AND WAS DIFFICULT TO ACCESS; HENCE, THE DIAMOND TIP INTRODUCER WAS HAMMERED THROUGH THE ILIUM AND INTO THE SACRUM. INTRA-OP, WHEN ATTEMPTING TO REMOVE THE CANNULA, IT PROVED TO BE DIFFICULT. THUS, CANNULA WAS TWISTED BACK AND FORTH WHILE YANKING, WITH THE PRODUCT STILL IN PLACE. WHILST PULLING THE DIAMOND TIP INTRODUCER ALONG WITH THE PURPLE PLASTIC, ASPECT OF THE WORKING CANNULA BROKE OFF. THE PRODUCT WAS PULLED OUT LEAVING THE METAL ONLY WORKING CANNULA PROTRUDING FROM THE HIP. THE SURGEON THEN GRABBED HEMOSTAT AND GRABBED THE PROTRUDING METAL AND BEGAN PULLING AND TWISTING THE EMPTY CANNULA. AT THIS TIME, THE METAL CANNULA WAS CRUSHED, AND THE METAL WAS TORN, WHICH CUT THE SURGEON¿S OWN HAND. THE SURGEON TRIED UNSUCCESSFULLY REINTRODUCING THE DIAMOND TIP INTRODUCER INTO THE CANNULA TO GET A BETTER GRIP. HE TRIED ONCE AGAIN GRABBING IT FROM A MORE DISTAL ASPECT AND ENDED UP SNAPPING IT OFF BENEATH THE SKIN. THE CANNULA WAS REIMAGED, AND IT APPEARED TO BE IN ITS ORIGINAL POSITION WITHIN THE SACRUM AND ILIUM, SNAPPED OFF AT THE ILIUM CORTEX. THE PROCEDURE WAS DELAYED

  Patient problems: Device Embedded In Tissue or Plaque; Injury

  MAUDE report 9367283 ↗