KYPHON® Express™ Inflatable Bone Tamp KE152Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00643169143777), received between Dec 16, 2016 and Sep 13, 2019 — classified as 3 injuries, 32 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, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionFeb 28, 2019Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT INTRA-OP, THE IBT INFLATED IMPROPERLY IN ONE DIRECTION. TIP OF IBT ALSO GOT BENT. HENCE, IT BECAME DIFFICULT TO INSERT THE IBT BACK INTO CANNULA AFTER IT WAS REMOVED TO EXAMINE IBT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8377009 ↗
• MalfunctionDec 11, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH T12 VERTEBRAL COMPRESSION FRACTURE AND UNDERWENT UNSPECIFIED PROCEDURE. DURING THE PROCEDURE,THE BALLOON WAS RUPTURED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8153720 ↗
• MalfunctionNov 29, 2018Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS: VERTEBRAL COMPRESSION FRACTURE (VCF) PERHAPS DUE TO MULTIPLE MYELOMA LEVELS IMPLANTED: L3 IT WAS REPORTED THAT ON 31 OCT 2018, INTRA-OP, THE BALLOON RUPTURED VERY EARLY IN THE INFLATION PROCESS, AT LOW PRESSURE AND LOW VOLUME. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WAS AN UNSPECIFIED DELAY IN THE OVERALL PROCEDURE AS THE RESULT OF THE EVENT, HOWEVER THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8117876 ↗
• MalfunctionNov 9, 2018Material Rupture; Material Rupture

  PATIENT MEDICAL HISTORY: OSTEOPOROSIS PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: PRIMARY OSTEOPOROSIS WITH COMPRESSION FRACTURES AT T12, L1, AND L2 VERTEBRAL BODIES LEVELS IMPLANTED: T12, L1, L2 IT WAS REPORTED THAT ON (B)(6) 2018, INTRA-OP, IBT (INFLATABLE BONE TAMP) RUPTURED AT 402 PSI AND 2CC AFTER COMING IN CONTACT WITH A BONE SHARD. THE DEFLATED IBT WAS UNABLE TO BE PULLED BACK THROUGH THE CANNULA. THE DOCTOR HAD TO PULL OUT ENTIRE TROCAR AND RE-ACCESS THE BONE. THERE WAS A DELAY OF 5 MINUTES IN OVERALL PROCEDURE TIME; HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8057802 ↗
• MalfunctionOct 12, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH T12 FRACTURE AND UNDERWENT BALLOON KYPHOPLASTY (BKP) SURGERY. DURING SURGERY, THE BALLOON RUPTURED AND WAS VERY DIFFICULT IN REMOVING FROM VERTEBRAL BODY. THE PRESSURE PRIOR TO RUPTURE WAS 275 MM HG AND VOLUME PRIOR TO RUPTURE WAS 3ML. NO PIECE OF THE BALLOON REMAINED IN THE PATIENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO HEALTH DAMAGE TO PATIENT HAS BEEN REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7959536 ↗
• InjuryJul 18, 2018Difficult to Remove; Retraction Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY DUE TO OSTEOPOROTIC COMPRESSION FRACTURE. INTRA-OP, WHEN TRYING TO REMOVE THE INFLATABLE BONE TAMP, IT STUCK ON A BONE SHARD IN THE PATIENT'S VERTEBRAL BODY. IT WAS DEFLATED BUT WOULD NOT COME OUT OF THE PATIENT. SURGEON THEN PULLED VERY HARD AND RIPPED THE INFLATABLE BONE TAMP AND CANNULA OUT OF THE PATIENT. THE RADIOPAQUE MARKERS DETACHED FROM THE INFLATABLE BONE TAMP AND REMAINED WITHIN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7698549 ↗
• InjuryJun 21, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY AT L1 DUE TO VERTEBRAL COMPRESSION FRACTURE. INTRA-OP, BALLOON RUPTURED AND THE MARKER GOT SEPARATED AND WAS LEFT IN THE VERTEBRAL BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7624839 ↗
• MalfunctionJun 10, 2018Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY AT T12. INTRA-OP, THE DOCTOR INFLATED THE BALLOON TO CREATE A CAVITY. AT THIS TIME THE LEFT BALLOON RUPTURED AND GOT STUCK IN THE CANNULA. THE SURGEON REMOVED THE CANNULA COMPLETELY AND FILL THE CAVITY WITH CEMENT UNIPEDICULAR. THE DEVICE CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE PROCEDURE COMPLETED SUCCESSFULLY WITH THE ORIGINAL DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7585432 ↗
• MalfunctionJun 8, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY (BKP) AT L3 DUE TO OSTEOPOROSIS, VERTEBRAL COMPRESSION FRACTURE DUE TO SHOVELING SNOW. DURING THE PROCEDURE, THE IBT(INFLATABLE BONE TAMP) BURST. THE IBT WAS USED TO INITIALLY REDUCE THE FRACTURE. THEN WAS LEFT INFLATED DURING CEMENT INJECTION ON THE CONTRALATERAL SIDE AND WAS ONLY LEFT INFLATED FOR FIRST 5 MINUTES. THE BALLOON WAS NOT REDUCED BY 1CC PRIOR TO INJECTING CEMENT ON THE CONTRALATERAL SIDE AND THE BALLOON WAS STILL INTACT. THE PHYSICIAN DEFLATED THE BALLOON AND THEN USED IT AGAIN TO CREATE AN EGGSHELL ON THE INFERIOR ENDPLATE. IT WAS AFTER THE BALLOON WAS INFLATED THAT IT BURST. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. THE PROCEDURE WAS COMPLETED WITH THE PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. .

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7581063 ↗
• MalfunctionApr 24, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY SURGERY DUE TO VERTEBRAL COMPRESSION FRACTURE AT L5. INTRA-OP, BALLOON BURSTED UPON FIRST ATTEMPT OF USE NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7454192 ↗
• MalfunctionApr 24, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY SURGERY DUE TO VERTEBRAL COMPRESSION FRACTURE AT L5. INTRA-OP, BALLOON BURSTED UPON FIRST ATTEMPT OF USE NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7454189 ↗
• MalfunctionMar 13, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH FRACTURE AT L3 AND UNDERWENT BALLOON KYPHOPLASTY. INTRA-OP, THE BALLOON RUPTURED WHILE INFLATING. THE IBT WAS FILLED TO ONLY 2.5 CC AND THE PSI WAS ABOUT 250 WHEN THE BALLOON RUPTURED ON THE RIGHT SIDE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE PATIENT WAS NOT ALLERGIC TO THE CONTRAST MEDIA. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7333888 ↗
• MalfunctionMar 13, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH FRACTURE AT L3 AND UNDERWENT BALLOON KYPHOPLASTY. INTRA-OP, THE BALLOON RUPTURED WHILE INFLATING. SURGEON WAS INFLATING IBT AT JUST ABOUT 3CC ON THE CONTRALATERAL SIDE AND THE PRESSURE DROPPED TO ZERO AND IT WAS DETERMINED THE BALLOON POPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE VOLUME AND PRESSURE OF THE IBT PRIOR TO RUPTURE WAS 3CC AND 250 PSI RESPECTIVELY. THE PATIENT WAS NOT ALLERGIC TO THE CONTRAST MEDIA. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7333883 ↗
• MalfunctionFeb 14, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY PROCEDURE AT L4/L5 DUE TO VERTEBRAL COMPRESSION FRACTURES. INTRA-OP, A 15MM INFLATABLE BONE TAMP (IBT) RUPTURED ON THE LEFT SIDE OF L5. AS PER THE SURGEON THERE MUST HAVE BEEN A BONE SHARD OR SOMETHING HARD WITHIN THE LEFT SIDE OF L5 THAT RUPTURED THE IBT THAT WAS INSERTED. THE PROCEDURE WAS SUCESSFULLY COMPLETED WITH THE ORIGINAL PRODUCT. NO FRAGMENTS OF THE IBT REMAINED INISIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7271051 ↗
• MalfunctionFeb 14, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY PROCEDURE AT L4/L5 DUE TO VERTEBRAL COMPRESSION FRACTURES. INTRA-OP, A 15MM INFLATABLE BONE TAMP (IBT) RUPTURED ON THE LEFT SIDE OF L5. AS PER THE SURGEON THERE MUST HAVE BEEN A BONE SHARD OR SOMETHING HARD WITHIN THE LEFT SIDE OF L5 THAT RUPTURED THE IBT THAT WAS INSERTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE ORIGINAL PRODUCT. NO FRAGMENTS OF THE IBT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7271043 ↗
• MalfunctionJan 4, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT, INTRA-OP, THE BONE TAMP RUPTURED DURING INFLATION AND WOULD NOT FIT BACK INTO THE CANNULA WHEN RETRIEVAL WAS ATTEMPTED. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7163229 ↗
• MalfunctionDec 8, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH VERTEBRAL COMPRESSION FRACTURE AND UNDERWENT AN UNSPECIFIED SURGERY AT T9. DURING SURGERY, THE BONE TAMP RUPTURED ON INFLATION. BONE TAMP CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THERE WAS A DELAY IN THE OVERALL PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7099236 ↗
• MalfunctionDec 8, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH VERTEBRAL COMPRESSION FRACTURE AND UNDERWENT AN UNSPECIFIED SURGERY AT T9. DURING SURGERY, THE BONE TAMP RUPTURED ON INFLATION. CONTRAST LEAKAGE WAS ALSO OBSERVED. BONE TAMP CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THERE WAS A DELAY IN THE OVERALL PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7099217 ↗
• MalfunctionOct 16, 2017Material Rupture; Material Rupture

  PRE-OP DIAGNOSIS: VCF (VERTEBRAL COMPRESSION FRACTURE) LEVELS IMPLANTED: L1 IT WAS REPORTED THAT DURING SURGERY, THE BALLOON RUPTURED WHEN THE CEMENT TOUCHED IT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6950689 ↗
• MalfunctionOct 11, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY PROCEDURE AT L1 DUE TO VERTEBRAL COMPRESSION FRACTURE. INTRA-OPERATIVELY, THE BALLOON RUPTURED. ONCE THE RUPTURE HAPPENED, IT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ORIGINAL PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6939471 ↗
• MalfunctionSep 25, 2017Material Rupture; Material Rupture

  PRE-OP DIAGNOSIS: VERTEBRAL COMPRESSION FRACTURE IT WAS REPORTED THAT THE BALLOON BURST DURING INFLATION. BALLOON CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6889489 ↗
• MalfunctionAug 9, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WITH COMPRESSION FRACTURE UNDERWENT BALLOON KYPHOPLASTY. DURING THE SURGERY, THE BALLOON RUPTURED DURING NORMAL INFLATION. A CURETTE WAS USED. PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. THERE WAS NO PATIENT COMPLICATION REPORTED FOR THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6776280 ↗
• MalfunctionAug 9, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WITH COMPRESSION FRACTURE UNDERWENT BALLOON KYPHOPLASTY. DURING THE SURGERY, THE BALLOON RUPTURED DURING NORMAL INFLATION. A CURRETTE WAS USED. PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. THERE WAS NO PATIENT COMPLICATION REPORTED FOR THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6776272 ↗
• MalfunctionJul 24, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY. INTRA-OP, THE BALLOON BURST AT THE PRESSURE LESS THAN 450 PSI. NO PATIENT COMPLICATION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6735202 ↗