KYPHON Xpander II Inflatable Bone TampRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 7 models of KYPHON Xpander II Inflatable Bone Tamp by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Feb 12, 2017 and Jan 11, 2022 — classified as 4 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (29 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 II Inflatable Bone Tamp problems
Device problems
- Material Rupture29
- Leak/Splash2
- Detachment Of Device Component1
- Material Puncture/Hole1
- Material Split, Cut or Torn1
- Torn Material1
Patient problems
- No Known Impact Or Consequence To Patient26
- Device Embedded In Tissue or Plaque3
- No Clinical Signs, Symptoms or Conditions2
- Blood Loss1
- Hematoma1
- No Patient Involvement1
KYPHON Xpander II Inflatable Bone Tamp models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 11 reports
- 9 reports
- 6 reports
- 3 reports
- 2 reports
- 1 report
- 1 report
Recent KYPHON Xpander II Inflatable Bone Tamp adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2022Material Rupture; Material Rupture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH VERTEBRAL COMPRESSION FRACTURE L4 INVOLVED IN THE BALLOON KYPHOPLASTY PROCEDURE. LEVELS IMPLANTED- L4. IT WAS REPORTED THAT INTRA-OPERATIVELY, DURING INFLATION IBT RUPTURED AT TOO LOW OF A PRESSURE AND VOLUME WAS USED WITH ANALOG ATRION INFLATION SYRINGE. PRESSURE PRIOR TO RUPTURE 200PS. BALLOON RUPTURE AT LOW PRESSURE. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. PATIENT WAS NOT HOSPITALIZED PROLONG AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. PROCEDURE WAS COMPLETED WITH ORIGINAL PRODUCT. PATIENT IS ALIVE AND NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13219834 ↗MalfunctionNov 26, 2020Material Rupture; Material Rupture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE (VCF) SUGGESTED FOR SPINAL THERAPY. LEVEL IMPLANTED WAS L3. EVENT OCCURRED INTRA-OP. IT WAS REPORTED BALLOON WAS INSERTED , PRESSURE REACHED NEAR 400 PSI , BALLOON RUPTURED DURING INFLATION. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS REPORTED. DEVICE IS BEING RETURNED. UPDATE; PROCEDURE/THERAPY USED ¿ BALLOON KYPHOPLASTY; IBT ISSUE WAS IT BURST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10910695 ↗MalfunctionSep 5, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L3 FRACTURE; AND UNDERWENT KYPHOPLASTY AT L3 AND VERTEBROPLASTY AT L2 AND L4. INTRA-OP, DURING DEFLATION, THE BALLOON BURST. THE BALLOON WAS INFLATED AND LEFT IN THE VERTEBRAL BODY WHILE THE SURGEON PLACED THE JAMSHIDIS FOR THE PLANNED VERTEBROPLASTY IN THE VERTEBRAE ABOVE AND BELOW. SUDDENLY, BLOOD WAS SEEN IN THE INFLATION SYRINGE. IT WAS CLEAR THAT THE BALLOON HAD BURST. THE SURGEON THEN PULLED OUT THE BALLOON AND CEMENTED THE VERTEBRA. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8965572 ↗MalfunctionSep 4, 2019Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH "BWK12" FRACTURE AND OSTEOPOROSIS; AND UNDERWENT BALLOON KYPHOPLASTY AT 1 LEVEL. INTRA-OP, AFTER DRILLING, THE SURGEON CLEANED THE BONE FRAGMENTS WITH THE BONE FILLER AS USUAL. BUT AFTER INSERTION OF THE INFLATABLE BONE TAMP THROUGH THE INTRODUCER, IT WAS NOT POSSIBLE TO INFLATE THE BALLOON. THE SURGEON REMOVED THE BALLOON AND DETECTED THAT THERE WAS A HOLE IN THE BALLOON DUE TO WHICH THE BALLOON COULD NOT BE INFLATED. A NEW KIT WAS THEN OPENED TO COMPLETE THE PROCEDURE. NO DELAY IN OVERALL PROCEDURE TIME WAS NOTED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8959748 ↗MalfunctionAug 16, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY DUE TO VERTEBRAL COMPRESSION FRACTURE. INTRA-OP, DURING INFLATION, THE BALLOON OF THE INFLATABLE BONE TAMP (IBT) BURST. STERILE WATER AND CONTRAST MEDIA MIXED IN THE RATIO 1:1 FLOWED OUT INTRAVERTEBRALLY. A NEW IBT WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME DUE TO THIS EVENT. PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT WERE UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8900681 ↗MalfunctionJul 18, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY SURGERY DUE TO VERTEBRAL COMPRESSION FRACTURE AT T12. INTRA-OP, BALLOON RUPTURED DURING INFLATION. BALLOONS WERE INSERTED AND INFLATED IN A BILATERAL BKP PROCEDURE. BALLOONS WERE INFLATED TO 3.5 -4 CC'S VOLUME, AT 350-400 PSI. THE BALLOON ON THE LEFT SIDE OF THE PATIENT RUPTURED AT THIS POINT. THE PHYSICIAN DREW BACK THE CONTRAST TO THE BEST OF HIS ABILITY, AND DEFLATED THE BALLOON ON THE RIGHT. HE REINSERTED THAT BALLOON ON THE LEFT SIDE, RE-INFLATED TO ORIGINAL VOLUME AND PRESSURE. THEN THE SECOND BALLOON RUPTURED. HE DREW BACK THE CONTRAST INTO THE SYRINGE AND COMPLETED THE PROCEDURE WITHOUT INCIDENT. NO ADDITIONAL TREATMENT OR SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT. NO DELAY IN OVERALL PROCEDURE AS A RESULT OF THIS EVENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8801449 ↗MalfunctionJul 18, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY SURGERY DUE TO VERTEBRAL COMPRESSION FRACTURE AT T12. INTRA-OP, BALLOON RUPTURED DURING INFLATION. BALLOONS WERE INSERTED AND INFLATED IN A BILATERAL BKP PROCEDURE. BALLOONS WERE INFLATED TO 3.5 -4 CC'S VOLUME, AT 350-400 PSI. THE BALLOON ON THE LEFT SIDE OF THE PATIENT RUPTURED AT THIS POINT. THE PHYSICIAN DREW BACK THE CONTRAST TO THE BEST OF HIS ABILITY, AND DEFLATED THE BALLOON ON THE RIGHT. NO ADDITIONAL TREATMENT OR SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT. NO DELAY IN OVERALL PROCEDURE AS A RESULT OF THIS EVENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8801430 ↗MalfunctionJul 12, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY SURGERY AT L4-L5 DUE TO VERTEBRAL COMPRESSION FRACTURE. INTRA-OP, THE BALLOON RUPTURED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8783818 ↗MalfunctionJul 5, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY (BKP) AT T12. INTRA-OP, THE BALLOON RUPTURED. BALLOON WAS INFLATED AT A LOW PRESSURE. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8763702 ↗MalfunctionJul 5, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY (BKP) AT T12. INTRA-OP, THE BALLOON RUPTURED. BALLOON WAS INFLATED AT A LOW PRESSURE. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8763689 ↗MalfunctionJun 13, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE PATIENT WAS PREOPERATIVELY DIAGNOSED WITH VERTEBRAL COMPRESSION FRACTURE; AND UNDERWENT VERTEBRAL AUGMENTATION. INTRA-OP, DISTAL END OF STYLET PROTRUDED FROM BALLOON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME PRODUCT; HOWEVER, THE PROCEDURE TIME WAS DELAYED FOR ABOUT 3 MINUTES TO INSPECT THE STYLET. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8697052 ↗MalfunctionMay 27, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT PATIENT UNDERWENT BALLOON KYPHOPLASTY AT T12 DUE TO COMPRESSION FRACTURE AT T 12. INTRA-OP, THE IBT RUPTURED. WHEN THE PHYSICIAN INSERTED BOTH TROCARS AS PLANNED THEN INSERTED BIOPSY DEVICE IN BOTH SIDES, THE PHYSICIAN DID NOT DRILL AND INSERTED THE IBT. THE PHYSICIAN BEGAN INFLATING IBT ROTATING BETWEEN RIGHT AND LEFT SIDES DURING INFLATION RIGHT THEN LEFT. WHEN RIGHT IBT WAS IN LOW 100 PSI RANGE AND APPROX 3 ML IT RUPTURED. THE PHYSICIAN REMOVED AND FLUSHED RIGHT SIDE WITH SALINE, THEN IT IS CONTINUE TO INFLATE LEFT IBT, IT RUPTURED SHORTLY AFTER, DOCTOR STATED APPROX 3-4 ML AND LOW TO MID 100 PSI RANGE. THE PHYSICIAN FLUSHED AGAIN WITH SALINE, THEN INSERTED CEMENT, APPROX 3.5 TO 4 ML PER SIDE AND COMPLETED CASE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8643543 ↗MalfunctionMay 27, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT PATIENT UNDERWENT BALLOON KYPHOPLASTY AT T12 DUE TO COMPRESSION FRACTURE AT T 12. INTRA-OP, THE IBT RUPTURED. WHEN THE PHYSICIAN INSERTED BOTH TROCARS AS PLANNED THEN INSERTED BIOPSY DEVICE IN BOTH SIDES, THE PHYSICIAN DID NOT DRILL AND INSERTED THE IBT. THE PHYSICIAN BEGAN INFLATING IBT ROTATING BETWEEN RIGHT AND LEFT SIDES DURING INFLATION RIGHT THEN LEFT. WHEN RIGHT IBT WAS IN LOW 100 PSI RANGE AND APPROX 3 ML IT RUPTURED. THE PHYSICIAN REMOVED AND FLUSHED RIGHT SIDE WITH SALINE, THEN IT IS CONTINUE TO INFLATE LEFT IBT, IT RUPTURED SHORTLY AFTER, DOCTOR STATED APPROX 3-4 ML AND LOW TO MID 100 PSI RANGE. THE PHYSICIAN FLUSHED AGAIN WITH SALINE, THEN INSERTED CEMENT, APPROX 3.5 TO 4 ML PER SIDE AND COMPLETED CASE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8643542 ↗MalfunctionJan 3, 2019Material Rupture; Material Rupture
PRE-OPERATIVE DIAGNOSIS: FRACTURE COMPACTION T12 LEVEL LEVEL IMPLANTED: T12 IT WAS REPORTED THAT INTRA-OP, BALLOON EXPLODED INTO THE VERTEBRA DURING DEFLATION. AFTER BEING INFLATED, THE CONTRAST LIQUID DIFFUSED INTO THE VERTEBRA. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8215430 ↗MalfunctionNov 27, 2018Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH FRACTURE OF VERTEBRAL BODY AND UNDERWENT BALLOON KYPHOPLASTY (BKP) PROCEDURE. DURING SURGERY, THE BALLOON BURST WHILE INFLATING AT NORMAL PRESSURE(UNDER 700 PSI).THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO COMPLICATIONS TO THE PATIENT WERE REPORTED AS A RESULT OF THE EVENT. THERE WAS NO DELAY IN PROCEDURE TIME AS A RESULT OF ALLEGED MALFUNCTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8104930 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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