KYPHON Xpander KyphoPak Tray KPT1502Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00763000031725), received between Dec 13, 2019 and May 22, 2026 — classified as 3 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (22 reports).

5 other recalls cover devices cleared under the same FDA submission (K041454); they may or may not involve this specific model.

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 25 most recent of 45 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 20, 2024Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR LAMINOP LASTY FOR PRIMARY OSTEOPOROSIS. TYPE OF FRACTURE: COMPRESSION FRACTURE. IT WAS REPORTED THAT DURING EXPANSION, THE BALLOON RUPTURED UPON INITIAL INSERTION. 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 18939040 ↗
• MalfunctionJan 18, 2024Material Puncture/Hole; Material Puncture/Hole

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PERCUTANEOUS VE RTEBROPLASTY FOR TH11 FOR PRIMARY OSTEOPOROSIS. TYPE OF FRACTURE: COMPRESSION FRACTURE IT WAS REPORTED THAT THE PRESSURE DID NOT INCREASE EVEN AFTER INSERTING THE BALLOON AND CHECKING THE MONITOR WHILE ATTEMPTING TO INFLATE IT. AFTER CHECKING THE IMAGE, IT WAS CONFIRMED THAT THE BALLOON WAS NOT INFLATED. THE BALLOON WAS REMOVED FROM THE PATIENT'S BODY AND A HOLE WAS OBSERVED IN THE BALLOON. THE OPERATION WAS COMPLETED WITH ONLY ONE BALLOON ON ONE SIDE WITHOUT OPENING A NEW ONE. 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 18532555 ↗
• MalfunctionDec 27, 2023Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAG NOSIS FOR PRIMARY OSTEOPOROSIS. TYPE OF FRACTURE COMPRESSION FRACTURE. PROCEDURE PERFORMED WAS TRANSCUTANEOUS VERTEBROPLASTY FOR L2. LEVEL AT WHICH IMPLANT PERFORMED WAS L2. IT WAS REPORTED THAT THE IBT RUPTURED. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS A OVERALL DELAY OF LESS THAN 60 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18407338 ↗
• MalfunctionNov 28, 2023Break; Material Rupture; Break; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN BALLOON KYPHOPLASTY SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS. LEVELS IMPLANTED WAS T12. IT WAS REPORTED THAT THE BALLOON WAS BROKEN. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE BALLOON WAS RUPTURED AND THERE ARE NO BROKEN FRAGMENTS OF BALLOON LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18214582 ↗
• MalfunctionNov 22, 2023Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAG NOSIS FOR PRIMARY OSTEOPOROSIS. TYPE OF FRACTURE WAS COMPRESSION FRACTURE. PROCEDURE PERFORMED WAS TRANSCUTANEOUS VERTEBROPLASTY FOR TH12 IT WAS REPORTED THAT THE LEFT AND RIGHT BALLOONS WERE FILLED 1CC EACH (WITHIN 100 PSI OF PRESSURE) AND THE IMAGE WAS CONFIRMED. WHEN ADDITIONAL FILLING WAS TRIED, THE PRESSURE DROPPED TO 0 AND RUPTURE WAS OBSERVED. BOTH THE LEFT AND RIGHT BALLOONS MAY HAVE RUPTURED AT THE SAME TIME. WHEN THE RIGHT BALLOON WAS RE-INFLATED AFTER BEING REMOVED OUTSIDE THE BODY, A SMALL HOLE WAS OBSERVED, AND ALTHOUGH IT GRADUALLY INFLATED, THERE WAS A LEAKAGE OF CONTRAST MEDIUM FROM THE HOLE. WHEN THE LEFT BALLOON WAS DEFLATED INSIDE THE BODY, BLOOD FROM THE VERTEBRAL BODY FLOWED BACK THROUGH THE TUBE, AND LIKE THE RIGHT BALLOON, IT WAS NOT INFLATED AT ALL WHEN IT WAS RE-INFLATED OUTSIDE THE BODY. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS A LESS THAN 60 MINUTES DELAY IN THE OVERALL PROCEDURE TIME. THE AMOUNT OF BLEEDING WAS SMALL IN PERCUTANEOUS VERTEBROPLASTY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18197048 ↗
• MalfunctionNov 21, 2023Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS OF COMPRESSION FRACTURE. IT WAS REPORTED THAT PERCUTANEOUS VERTEBROPLASTY AT TH12 WAS DONE AND THE BALLOON ON THE LEFT SIDE WAS BROKEN. THE BALLOON WAS TRIED TO BE INSERTED ONCE, BUT IT DID NOT GO IN. AFTER ADDING A DRILL, THE BALLOON WAS INSERTED AGAIN. WHEN THE BALLOON WAS INFLATED, THE PRESSURE DID NOT INCREASE AND IT WAS DISCOVERED THAT THE BALLOON HAD RUPTURED.   THERE WAS NO DELAY IN THE OVERALL PROCEDURE TIME. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PATIENT EXPERIENCED A CONTRAST MEDIUM LEAK. WHEN THE PHYSICIAN TURNED THE INFLATION SYRINGE HANDLE TO INFLATE THE BALLOON ON THE LEFT SIDE, THE CONTRAST MEDIUM SPREAD OUT IN ACCORDANCE WITH THE SHAPE OF THE VERTEBRAL BODY.

  Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18180118 ↗
• MalfunctionOct 27, 2023Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR LAMINOPL ASTY FOR PRIMARY OSTEOPOROSIS. TYPE OF FRACTURE : COMPRESSION FRACTURE IT WAS REPORTED THAT THE BALLOON RUPTURED DURING INFLATION. THERE WAS A DELAY IN THE PROCEDURE BY LESS THAN 60 MINUTES. 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 18017937 ↗
• MalfunctionAug 17, 2023Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2 BKP FOR COMP RESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE BALLOON BROKE DURING INFLATION DURING THE INITIAL INSERTION INTO THE VERTEBRAL BODY. THERE WAS NO FRAGMENT OF THE BALLOON REMAINING IN THE PATIENT'S BODY. THERE WAS A DELAY OG LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW PRODUCT. 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 17562008 ↗
• MalfunctionAug 16, 2023Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR COMPRESSION FRACTURE ASSOCIATED WITH OSTEOPOROSIS. IT WAS REPORTED THAT, THE BALLOON BREAKAGE IN THE VERTEBRAL BODY. THE BALLOON WAS RUPTURED AT HIGH PRESSURE. THERE WERE NO FRAGMENTS OF BROKEN BALLOON LEFT INSIDE PATIENT BODY. THERE WAS A DELAY OF LESS THAN 60MINUTES OCCURRED AS A RESULT. THE BALLOON BREAKAGE OCCURRED, SO THE PROCEDURE WAS CONTINUED ONLY WITH ONE BALLOON. THERE WERE NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17555401 ↗
• MalfunctionJul 26, 2023Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING KYPHOPLASTY FOR PRIMARY OSTEOPOROSIS COMPRESSION FRACTURE. IT WAS REPORTED THAT BOTH BALLOONS RUPTURED ALMOST SIMULTANEOUSLY WHEN INFLATING THE BALLOON IN THE VERTEBRAL BODY WHILE CHECKING WITH FLUOROSCOPY IMAGES, ANOTHER LOT WAS OPENED AND BKP PROCEDURE RESUMED. THERE WAS NO PATIENT SYMPTOMS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17394970 ↗
• MalfunctionJul 6, 2023Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A BALLOON USED IN BKP THERAPY FOR VERTEBRAL FRACTURE. LEVELS IMPLANTED: L3 IT WAS REPORTED THAT THE BALLOON BROKE INSIDE THE BODY, WHEN IT WAS OPENED. AFTER CLEANING THE INSIDE OF THE VERTEBRAL BODY, THE PROCEDURE WAS RESUMED USING 1 BALLOON. THERE WAS A DELAY OF ABOUT 5 MINUTES. PATIENT SYMPTOMS ARE UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17268445 ↗
• MalfunctionJun 22, 2023Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING KYPHON KIT. IT WAS REPORTED THAT BALLOON RUPTURED DURING INFLATION. AFTER THE BALLOON BREAKAGE CONDITION WAS CONFIRMED, IT WAS ALSO CONFIRMED THAT NO FRAGMENT REMAINED IN THE BODY. THE BALLOON WAS SUFFICIENTLY INFLATED, SO IT WAS CLEANED IN THE VERTEBRAL BODY, THE CONTRAST MEDIUM WAS FLUSHED, AND THEN IT WAS FILLED WITH CEMENT AS USUAL. PATIENT HAS RECOVERED FROM THE AILMENTS THERE WAS A DELAY OF AROUND LESS THAN 60 MINUTES IN THE PROCEDURE. THE IBT FAILED DURING THE FIRST INSERTION ATTEMPT INTO THE VERTEBRAL BODY. THE CONTRAST FLUID FLOWED INTO THE VERTEBRAL BODY. THERE WAS NO REVISION SURGERY PLANNED/ OCCURRED AS A RESULT OF THE EVENT. PRE-OPERATIVE DIAGNOSIS FOR THE PATIENT WAS PRIMARY OSTEOPOROSIS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ORIGINAL PRODUCT. NO ADVERSE EVENT OCCURRED TO PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17179227 ↗
• MalfunctionMay 25, 2023Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN BALLOON KYPHOPLASTY PROCEDURE FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE BALLOON WAS RUPTURED DURING EXPANSION. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. LEVELS IMPLANTED WAS TH12.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17001885 ↗
• MalfunctionMay 11, 2023Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING KYPHOPLASTY FOR COMPRESSION FRACTURE. IT WAS REPORTED THAT WHEN THE WHEN THE BALLOON WAS INFLATED INSIDE THE PATIENT'S BODY, IT RUPTURED. CONTRAST AGENT LEAKED. THERE WERE NO PATIENT SYMPTOMS AS A RESULT OF THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16909758 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041454. One submission often covers many models, so check the product and lot details in each record.

• Z-2390-2020 · Apr 24, 2020 · Terminated
  Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit c
• Z-2389-2020 · Apr 24, 2020 · Terminated
  Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Ki
• Z-2391-2020 · Apr 24, 2020 · Terminated
  Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit c
• Z-3175-2011 · Mar 23, 2011 · Terminated
  Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Product is manufactured and distributed by Medtronic Spine LLC
• Z-1209-2009 · Feb 4, 2009 · Terminated
  KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery.