KYPHON Xpander KyphoPak TrayRecalls & reported problems across all models

We found 5 models of KYPHON Xpander KyphoPak Tray by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2019 and May 22, 2026 — classified as 3 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (30 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported KYPHON Xpander KyphoPak Tray problems

KYPHON Xpander KyphoPak Tray models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• KYPHON Xpander KyphoPak Tray KPT1502

  Arthroscope
  45 reports
• KYPHON Xpander KyphoPak Tray KPT1002

  Arthroscope
  5 reports
• KYPHON Xpander KyphoPak Tray KPT2002

  Arthroscope
  3 reports
• KYPHON Xpander KyphoPak Tray KPT1505

  Arthroscope
  2 reports
• KYPHON Xpander KyphoPak Tray KPT2005

  Arthroscope
  1 report

Recent KYPHON Xpander KyphoPak Tray adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY PROCEDURE FOR PRIMARY OSTEOPOROSIS AND A COMPRESSION FRACTURE AT T10 LEVEL. IT WAS REPORTED THAT A RESISTANCE WAS ENCOUNTERED WHEN ATTEMPTING TO PASS A GUIDEWIRE THROUGH AN OSTEO INTRODUCER STYLET DURING PATHWAY CREATION, AS THE GUIDEWIRE DID NOT PASS THROUGH THE HOLLOW PORTION AS EXPECTED. WHEN THE DEVICE WAS TESTED OUTSIDE THE SURGICAL FIELD, A CATCHING SENSATION WAS FELT WITHIN THE STYLET LUMEN, WHICH RESOLVED ONLY AFTER APPLYING FORCE AND REPEATEDLY PASSING THE GUIDEWIRE THROUGH. BECAUSE MULTIPLE KITS WERE OPENED FOR TREATMENT OF THREE VERTEBRAL BODIES, THE EXACT KIT COULD NOT BE IDENTIFIED; HOWEVER, THE SAME GUIDEWIRE PASSED SMOOTHLY THROUGH OTHER STYLETS, INDICATING THE ISSUE WAS SPECIFIC TO THE AFFECTED OSTEO INTRODUCER RATHER THAN THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NEW PRODUCT, WITH NO DELAY, COMPLICATIONS, OR PATIENT HARM REPORTED, ALTHOUGH IT WAS NOTED THAT UNEXPECTED GUIDEWIRE RESISTANCE IN AN OSTEOPOROTIC PATIENT COULD PRESENT A SIGNIFICANT SAFETY RISK. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25252099 ↗
• MalfunctionMay 21, 2026Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY PROCEDURE FOR PRIMARY OSTEOPOROSIS AND A COMPRESSION FRACTURE AT T10 LEVEL. IT WAS REPORTED THAT A RESISTANCE WAS ENCOUNTERED WHEN ATTEMPTING TO PASS A GUIDEWIRE THROUGH AN OSTEO INTRODUCER STYLET DURING PATHWAY CREATION, AS THE GUIDEWIRE DID NOT PASS THROUGH THE HOLLOW PORTION AS EXPECTED. WHEN THE DEVICE WAS TESTED OUTSIDE THE SURGICAL FIELD, A CATCHING SENSATION WAS FELT WITHIN THE STYLET LUMEN, WHICH RESOLVED ONLY AFTER APPLYING FORCE AND REPEATEDLY PASSING THE GUIDEWIRE THROUGH. BECAUSE MULTIPLE KITS WERE OPENED FOR TREATMENT OF THREE VERTEBRAL BODIES, THE EXACT KIT COULD NOT BE IDENTIFIED; HOWEVER, THE SAME GUIDEWIRE PASSED SMOOTHLY THROUGH OTHER STYLETS, INDICATING THE ISSUE WAS SPECIFIC TO THE AFFECTED OSTEO INTRODUCER RATHER THAN THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NEW PRODUCT, WITH NO DELAY, COMPLICATIONS, OR PATIENT HARM REPORTED, ALTHOUGH IT WAS NOTED THAT UNEXPECTED GUIDEWIRE RESISTANCE IN AN OSTEOPOROTIC PATIENT COULD PRESENT A SIGNIFICANT SAFETY RISK. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240136 ↗
• MalfunctionApr 29, 2025Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR KYPHOP LASTY SPINAL THERAPY. IT WAS REPORTED THAT THE IBT DID NOT RETURN WHEN IT WAS PULLED UP. EVEN THE LCD WAS LIT RED, BUT THE NUMBERS DID NOT COME OUT ANYMORE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE IBT WAS PULLED OUT AND IT DIDN'T COME BACK. THE LIQUID CRYSTAL ALSO GLOWED RED AND NO NUMBERS CAME OUT WHEN PREPARING FOR THE IBT, THE HANDLE WAS PULLED TO APPLY NEGATIVE PRESSURE, BUT THEN THE HANDLE DID NOT RETURN. IT HAPPENED AT THE BACK TABLE. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE LOCK ON THE HANDLE CAN BE GRIPPED (ALTHOUGH IT IS NOT WORKING), THE ISSUE SHOULD BE ON IBT. IBT COULDN'T BE UNDONE ONCE PULLED IT BACK. IT IS NO LONGER POSSIBLE TO SET THE SYSTEM FROM NEGATIVE PRESSURE TO PRESSURIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21924742 ↗
• MalfunctionMar 12, 2025Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE IN A PATIENT DIAGNOSED WITH COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE SECOND OSTEO-INTRODUCER COULD NOT BE SET UP. WHEN THE STYLET WAS INSERTED INTO THE CANNULA, IT GOT STUCK IN THE MIDDLE AND COULD NOT BE ADVANCED TO THE END. UPON LOOKING INSIDE THE CANNULA, THERE WAS SOMETHING RESEMBLING A BURR, SO THE PRODUCT WAS REPLACED WITH A NEW ONE. THERE WAS A DELAY OF LESS THAN 60 MINS. THE PROCEDURE FOLLOWED THE PROCEDURE INSTRUCTION. THE OSTEO INTRODUCER ORIGINALLY SET WAS USED, BUT THE REPORTED PRODUCT WAS NOT USED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583736 ↗
• MalfunctionFeb 18, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR LAMINOPL ASTY SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS. TYPE OF FRACTURE (COMPRESSION FRACTURE). IT WAS REPORTED THAT BALLOON WAS RUPTURED DURING EXPANSION AND CURETTE COULD NOT CHANGE THE ANGLE DUE TO WIRE BREAKAGE. THERE WAS A DELAY OF LESS THAN 60 MINUTES AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE EVENT OCCURRED DURING NORMAL USAGE OF PRODUCTS AND NO MANUFACTURING ISSUE SUSPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392098 ↗
• MalfunctionJan 15, 2025Difficult to Insert; Difficult to Insert

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING KYPHOPLASTY SPI NAL THERAPY FOR PRIMARY OSTEOPOROSIS (TYPE OF FRACTURE IS COMPRESSION FRACTURE). IT WAS REPORTED THAT THE BALLOON COULD NOT BE INSERTED THROUGH THE INTRODUCER. THERE WAS A DELAY LESS THAN 60 MINUTES AND NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE EVENT OCCURRED DURING NORMAL USAGE OF PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21156628 ↗
• MalfunctionDec 31, 2024Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM REGULATORY BODY (RB), HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING KYPHOPLASTY SPINAL THERAPY FOR OSTEOPOROTIC FRACTURE. IT WAS REPORTED THAT THE BALLOONS WERE DAMAGED AND BUSTED DURING INFLATION PROCESS. THERE WAS DELAY IN OVERALL PROCEDURE TIME AND IT EXTENDED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THIS EVENT OCCURRED DURING NORMAL USAGE OF PRODUCTS AND NO SUSPECTED MANUFACTURING ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047553 ↗
• MalfunctionNov 28, 2024Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE BALLOON WAS FOUND RUPTURED ON THE DISTAL END OF THE DISTAL POLE, AND VACUUM COULD NOT BE CREATED TO INFLATE THE BALLOON. IT WAS NOTICED BEFORE INSERTING THE BALLOON IN PATIENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20805427 ↗
• MalfunctionNov 19, 2024Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE BALLOON KYPHOPLASTY FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT WHEN THE BALLOON WAS INFLATED BY 1 ML, A FEW DROPS OF CONTRAST AGENT LEAKED OUT FROM THE BIFURCATED NEEDLE PORTION OF THE BALLOON, SO THE BALLOON WAS DEFLATED AND REPLACED WITH A NEW ONE. NO LEAKAGE OF CONTRAST AGENT INTO THE SPINAL CORD WAS OBSERVED IN THE IMAGES. LEVEL TH11. NO PATIENT SYMPTOMS WERE REPORTED. NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20725161 ↗
• MalfunctionSep 25, 2024Difficult to Insert; Product Quality Problem; Material Deformation; Difficult to Insert; Product Quality Problem; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT WILL BE USED IN SPINAL FUSION THERAPY FOR PRIMARY OSTEOPOROSIS (TYPE OF FRACTURE WAS COMPRESSION FRACTURE). IT WAS REPORTED THAT WHEN TRIED TO PASS THE OSTEOINTRODUCER THROUGH THE GUIDEWIRE, BUT IT DID NOT PASS WELL. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301558 ↗
• MalfunctionAug 26, 2024Leak/Splash; Device Damaged Prior to Use; Leak/Splash; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BKP FOR L2 VERT EBRAL COMPRESSION FRACTURE FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE 3-WAY STOPCOCK WAS DAMAGED WHEN THE KIT WAS UNBOXED. HOWEVER, SETTING WAS PERFORMED BECAUSE THERE SEEMED TO BE NO PROBLEMS WITH THE IBT ITSELF. THERE WERE NO PROBLEMS WITH NEGATIVE PRESSURE AT THE TIME OF SETTING, BUT CONTRAST AGENT LEAKAGE WAS CONFIRMED FROM THE CONNECTOR OF THE TIP OF THE INFLATION SYRINGE AND THE IBT CONNECTION WHEN THE IBT WAS PLACED IN THE VERTEBRAL BODY AND EXTENDED. A NEW KPT1002 WAS UNBOXED AND ANOTHER SET ASSEMBLED, AND BALLOON INFLATION WAS RESUMED AFTER A DELAY OF ABOUT 5 MINUTES. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20062016 ↗
• MalfunctionJun 4, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN DECOMPRESSION AND ROD REPLACEMENT REVISION SURGERY FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT AFTER BALLOON INFLATION, THE TRIGGER WAS SQUEEZED, AND THE HANDLE WAS FULLY PULLED, BUT IT WAS NOT COLLECTED, AND THERE WAS AN ISSUE. AFTER SEVERAL REPETITIONS, IT APPEARED TO HAVE DEFLATED. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WERE NO FRAGMENTS LEFT INSIDE PATIENT BODY AND NO PATIENT SYMPTOMS REPORTED AS A RESULT. SINCE THE BALLOON DID NOT DEFLATE, IT SEEMS THAT IT WAS BROKEN WITH A CURETTE AND DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457071 ↗
• MalfunctionMay 27, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PERCUTANEOUS VE RTEBROPLASTY FOR AN INDICATION OF PRIMARY OSTEOPOROSIS (VERTEBRAL COMPRESSION FRACTURE). IT WAS REPORTED THAT THE BALLOON WAS RUPTURED DURING INFLATION AT L4. NO ADDITIONAL EXPANSION WAS REQUIRED, SO AFTER CLEANING AND CHECKING THE IMAGE, FILLED IT IN WITH CEMENT. THERE WAS A DELAY OF LESS THAN 60 MINS REPORTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19399348 ↗
• MalfunctionMay 21, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY FOR COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE BALLOON RUPTURED DURING CONTRACTION. THE CONTRAST AGENT LEAKED WHEN THE BALLOON WAS REMOVED; WHEN IT WAS CHECKED OUTSIDE THE SURGICAL FIELD AFTERWARDS, THE CONTRAST AGENT LEAKED FROM THE TIP. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19357461 ↗
• MalfunctionMar 25, 2024Break; Leak/Splash; Decrease in Pressure; Break; Leak/Splash; Decrease in Pressure

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A KYPHON INFLATABLE BONE TAMP USED ON THE PATIENT HAVING BALLOON KYPHOPLASTY THERAPY FOR PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE. IT WAS REPORTED THAT AFTER 4 ROTATIONS ON BOTH SIDES, CONTRAST AGENT 2CC FILLING WAS CONFIRMED. WHEN THE CEMENT MIXING OPERATION WAS ABOUT TO START, THE PRESSURE ON THE RIGHT SIDE DROPPED, AND THE CONTRAST AGENT LEAKAGE WAS CONFIRMED ON THE IMAGE. BALLOON DAMAGE WAS REPORTED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT PRODUCT WAS INSERTED INTO THE BODY AND EXPANDED. AFTER EXPANDING THE BALLOON, IT WAS RETRACTED ONCE, THE POSITION WAS ADJUSTED, AND WHEN IT WAS EXPANDED AGAIN, THE PRESSURE GRADUALLY DECREASED, AND THE LEAKAGE OF THE CONTRAST AGENT WAS CONFIRMED. THERE WAS NO REVISION SURGERY PLANNED/ OCCURRED AS A RESULT OF THE EVENT. BALLOON WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18970329 ↗

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