KYPHON Express Inflatable Bone TampRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 78
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 9 models of KYPHON Express Inflatable Bone Tamp by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 78 adverse event reports in the FDA's MAUDE database, received between Dec 16, 2016 and Mar 6, 2024 — classified as 10 injuries, 68 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (67 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
Reports received per month, all models
Most reported KYPHON Express Inflatable Bone Tamp problems
Device problems
- Material Rupture67
- Inflation Problem5
- Burst Container or Vessel3
- Leak/Splash3
- Difficult to Remove2
- Break1
- Detachment of Device or Device Component1
- Device Slipped1
Patient problems
- No Known Impact Or Consequence To Patient54
- No Consequences Or Impact To Patient11
- Device Embedded In Tissue or Plaque9
- Foreign Body In Patient2
- No Code Available2
- No Clinical Signs, Symptoms or Conditions1
KYPHON Express Inflatable Bone Tamp models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 35 reports
- 10 reports
- KYPHON® Express™ Inflatable Bone Tamp KE202ARTHROSCOPE8 reports
- KYPHON Express Inflatable Bone Tamp K15BArthroscope7 reports
- KYPHON® Express™ Inflatable Bone Tamp K15BARTHROSCOPE5 reports
- KYPHON Express Inflatable Bone Tamp K15AArthroscope4 reports
- KYPHON® Express™ Inflatable Bone Tamp K15AARTHROSCOPE4 reports
- KYPHON® Express™ Inflatable Bone Tamp K15BArthroscope3 reports
- KYPHON® Express™ Inflatable Bone Tamp K15BARTHROSCOPE2 reports
Recent KYPHON Express 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.
MalfunctionMar 6, 2024Material Rupture; Mechanical Jam; Material Rupture; Mechanical Jam
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING KYPHOPLASTY FOR VERTEBRAL COMPRESSION FRACTURE. IT WAS REPORTED THAT THE BALLOON POTENTIALLY MALFUNCTIONED DURING A PROCEDURE. THE BALLOON RADIOPAQUE MARKERS/ BALLOON BECAME STUCK IN THE PATIENT AND BROKE OFF IN THE VERTEBRAL BODY. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18843661 ↗MalfunctionJan 3, 2022Material Rupture; Material Rupture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED PRODUCT. THE PRE-OP DIAGNOSIS WAS MENTIONED AS COMPRESSION FRACTURE. IT WAS REPORTED THAT, BALLOON RUPTURED DURING INFLATION. WHILE ATTEMPTING TO WITHDRAW THE DEVICE, PART OF THE POLYMER BALLOON SEPARATED FROM THE BODY OF THE BALLOON AND WAS NOT RETRIEVABLE. THERE WAS NO DELAY IN PROCEDURE REPORTED. THERE WERE NO SYMPTOMS TO PATIENT OR PHYSICIAN AND NO HOSPITALIZATION WAS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 13140499 ↗MalfunctionJul 3, 2020Material Rupture; Material Rupture
PRE-OPERATIVE DIAGNOSIS:COMPRESSION FRACTURE PROCEDURE: KYPHOPLASTY LEVELS TREATED : T8 INTRA-OP, BALLOON POPPED(RUPTURED) WHILE INFLATING IN THE PATIENT¿S T8 VERTEBRAL BODY. THE MAXIMUM VOLUME WAS 2CC¿S WITH A PRESSURE OF 150PSI. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE ORIGINAL PRODUCT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10229109 ↗MalfunctionMay 12, 2020Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash
IT WAS REPORTED THAT THE PATIENT UNDERWENT UNKNOWN SURGERY. INTRA-OP, BALLOON FAILED TO INFLATE WITH CONTRAST. CONTRAST WAS LEAKING INTO VERTEBRAL BODY UNDER FLUOROSCOPY. IT WAS REPLACED WITH ANOTHER BALLOON OF THE SAME SIZE, AND THE PROCEDURE WAS COMPLETED. THE MALFUNCTION WAS DISCOVERED WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON IN THE VERTEBRAE. THERE WERE NO PATIENT COMPLICATIONS, BUT CONTRAST LEAKED INTO THE VERTEBRAE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10045968 ↗MalfunctionMar 25, 2020Material Rupture; Material Rupture
PRESSURE PRIOR TO RUPTURE- 300 VOLUME PRIOR TO RUPTURE- 3 ML IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY UNILATERAL AT T8 DUE TO VERTEBRAL COMPRESSION FRACTURE. INTRA-OP, T8 OSTEOCOOL PROCEDURE WAS COMPLETED. THE PROBES WAS REMOVED AND WAITED FOR 30 SECONDS, THEN THE INFLATABLE BONE TAMPS (IBT) WAS INSERTED AND INFLATED. IT BURST AT LOW PRESSURE AND LOW VOLUME. THERE WAS A CONTRAST OBSTRUCTED VIEW OF CEMENT IMPLANTATION. THE OPERATION WAS COMPLETED USING NEW PRODUCT. THERE WAS A DELAY IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9876506 ↗MalfunctionMar 20, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L1 VERTEBRAL COMPRESSION FRACTURE; AND UNDERWENT L1 BALLOON KYPHOPLASTY. INTRA-OP, WHILE RE-INTRODUCING THE INNER STYLET INTO THE BONE TAMP, THE BONE TAMP BURST INSIDE THE PATIENT. THE STYLET PIERCED THE INFLATED BALLOON. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9862812 ↗MalfunctionDec 25, 2019Inflation Problem; Device Slipped; Inflation Problem; Device Slipped
IT WAS REPORTED THAT THE PATIENT UNDERWENT UNKNOWN SURGERY AT L1-L2 DUE TO 2 LEVEL COMPRESSION FRACTURE. INTRA-OP, THE BALLOON WOULD NOT EXPAND INITIALLY BECAUSE THE BAND ON THE PROXIMAL PORTION OF THE BALLOON THAT HAS THE SIZE OF THE KIT ON IT (15/2) WAS LOOSE. IT SLIDES UP AND DOWN SHAFT OF THE BALLOON AND COULD ACCIDENTALLY BE IMPLANTED IN THE PATIENT. IT WAS NOT NOTICED AND THE BALLOON WENT UP TO 700 PSI. LATER IT SLIPPED OUT OF THE BAND AND EXPANDED RAPIDLY. THERE WAS DELAY IN OVERALL PROCEDURE TIME AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE ORIGINAL PRODUCT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATION REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9517651 ↗MalfunctionOct 28, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT L5 DUE TO FRACTURE. INTRA-OP, DURING INFLATION, THE BALLOON OF THE INFLATABLE BONE TAMP (IBT) BURST AT 200 PSI. THIS WAS THE SECOND BALLOON THAT RUPTURED DURING THIS CASE. HENCE, THE CASE WAS ABLE TO BE COMPLETED WITH THE CAVITY THAT WAS CREATED BEFORE THE BALLOONS BURST. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9243509 ↗MalfunctionOct 28, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT L5 DUE TO FRACTURE. INTRA-OP, DURING INFLATION, THE BALLOON OF THE INFLATABLE BONE TAMP (IBT) BURST AT 200 PSI. THE BALLOON WAS IMMEDIATELY DEFLATED AND WAS REPLACED WITH A SECOND IBT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9243500 ↗MalfunctionSep 13, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY AT L3. INTRA-OP, THE BALLOON RUPTURED DURING INFLATION. THE PATIENT WAS NOT ALLERGIC TO THE CONTRAST MEDIA. IT IS UNKNOWN IF ANY FRAGMENT OF THE RUPTURED BALLOON REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9021244 ↗MalfunctionAug 30, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY DUE TO VERTEBRAL COMPRESSION FRACTURE. INTRA-OP, IBT RUPTURED DURING PROCEDURE. IBT RUPTURED AT 285 PSI. THERE WAS NO RESISTANCE AND BALLOON PRESSURE KEPT COMING DOWN WHEN INFLATED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8949234 ↗InjuryAug 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY DUE TO COMPRESSION FRACTURE. INTRA-OP, WHEN THE PHYSICIAN DEFLATED THE INFLATABLE BONE TAMP (IBT) AND WAS REMOVING IT, THE BALLOON PORTION DETACHED FROM THE IBT. THE BALLOON PORTION REMAINED IN THE VERTEBRAL BODY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8887333 ↗MalfunctionJul 12, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT T11 AND T12 DUE TO MELANOMA WITH DIFFUSE BONE TUMORS THROUGHOUT SPINE. INTRA-OP, DURING BALLOON INFLATION, THE BALLOON RUPTURED. PRESSURE OF THE BALLOON PRIOR TO RUPTURE WAS 350 PSI AND VOLUME PRIOR TO RUPTURE WAS 2CC. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. THE PROCEDURE WAS COMPLETED WITH A NEW PRODUCT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME; AND NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8784119 ↗MalfunctionMay 22, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT L1 DUE TO VERTEBRAL COMPRESSION FRACTURE (VCF). INTRA-OP, UPON INFLATION THE IBT RUPTURED AT 150 PSI. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8630610 ↗MalfunctionApr 19, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT L4 DUE TO BONE FRACTURE. INTRA-OP, THE BALLOON RUPTURED DURING INFLATION AT 350 PSI. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. THE PROCEDURE WAS EVENTUALLY COMPLETED WITH A NEW PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8531171 ↗
Other Medtronic Sofamor Danek, Inc. products
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- METRx System5 models · 672 reports
- INFUSE Bone Graft6 models · 576 reports · 1 recall
- CD HORIZON SOLERA VOYAGER Spinal System60 models · 411 reports
- POWEREASE Instruments8 models · 331 reports · 1 recall
- Catalyft PL Expandable Interbody System16 models · 279 reports · 1 recall
- INFINITY Occipitocervical Upper Thoracic System35 models · 63 reports · 5 recalls
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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