KYPHON Xpander™ Inflatable Bone Tamp K09A (UDI 00858196001161)Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00858196001161), received between Dec 13, 2016 and May 20, 2020 — classified as 1 injury, 40 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (33 reports).

1 FDA recall record name this device's identifier.

4 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 16, 2026.

Recalls naming this device

1. Feb 4, 2009Terminated

   Product not sterile: 10 units were released for distribution without undergoing sterilization process.

   Z-1209-2009 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY (BKP) SURGERY DUE TO PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE. INTRA-OP, THE BALLOON RUPTURED ON ONE SIDE DURING INFLATION. SINCE THE BALLOON RUPTURED AFTER THE BALLOON WAS INFLATED TO AN ENOUGH EXTENT, THE BALLOON COULD NOT BE REPLACED WITH ANOTHER BALLOON. THE OPERATION WAS CONTINUED AND WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10073630 ↗
• MalfunctionMar 2, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS KYPHOPLASTY SURGERY DUE PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE. INTRA-OP, AFTER INFLATING THE BALLOON, THE BALLOON WAS PULLED OUT FOR THE NEXT PROCEDURE BUT THE BALLOON WAS BROKEN. THE VOLUME BEFORE BREAKAGE WAS 4CC, AND THE PSI WAS ABOUT 150. AFTER WASHING THE CONTRAST MEDIA WITH SALINE, SUCTION WAS PERFORMED AND THEN THE IMAGE WAS CHECKED. IT WAS JUDGED THAT THERE WAS NO PROBLEM WITH THE PROCEDURE, AND THE CEMENT WAS FILLED. THERE WAS A DELAY OF LESS THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING THE ORIGINAL PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9773464 ↗
• MalfunctionJan 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS VERTEBROPLASTY SURGERY DUE TO PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE. INTRA-OP, IBT (INFLATION BONE TAMP) WAS RUPTURED. WHEN THE IBT WAS INSERTED INTO THE VERTEBRAL BODY, THE MARKER WAS NOT IN A STRAIGHT LINE, SO IT WAS REMOVED. THE BALLOON HAD RUPTURED AT THE TIME OF REMOVAL. IT WAS BEFORE TURNING THE HANDLE OF THE INFLATION SYRINGE. THE SAME ISSUE OCCURRED ON BOTH SIDES. IT WAS CHECKED OUTSIDE THE PATIENT¿S BODY THAT THE BALLOON RUPTURED AND THE STYLET HAD POPPED OUT. IN THE OPINION OF SALES REP, THE BONE HAS BEEN HARD AND THERE WAS AN IMPRESSION THAT THE SURGEON HAD PUSHED THE IBT IN. CURETTE WAS NOT USED. THEREFORE, DRILLING WAS PERFORMED AGAIN, AND ANOTHER PRODUCT WAS OPENED AND USED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9594629 ↗
• MalfunctionDec 26, 2019Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY SURGERY DUE TO COMPRESSION FRACTURE. INTRA-OP, THE INFLATABLE BONE TAMPS (IBT) WAS PLACED IN THE VERTEBRAL BODY AND WHEN IT WAS ATTEMPTED TO INFLATE THE BALLOON, THE BALLOON DID NOT INFLATE EVEN THOUGH THE HANDLE WAS ROTATED. AND THE PRESSURE DID NOT INCREASE EITHER, SO THE BALLOON WAS REPLACED WITH A SPARE ONE. THEN THE OPERATION WAS CONTINUED AND WAS COMPLETED WITHOUT ANY PROBLEM. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9518106 ↗
• MalfunctionJan 3, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH COMPRESSION FRACTURE AND UNDERWENT BALLOON KYPHOPLASTY(BKP) SURGERY AT L2 LEVEL. DURING SURGERY. AFTER BALLOON WAS INFLATED WITH A LIQUID, WHICH IS ABOUT 3 CC, THE PHYSICIAN COULD NOT DEFLATE AND REMOVE THE BALLOON. LATER, THE PHYSICIAN USED THE SYRINGE TO EXHAUST SOME LIQUID OUT AND BALLOON BECOME SMALLER TO REMOVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8211367 ↗
• MalfunctionJan 2, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH VERTEBRAL COMPRESSION FRACTURES (VCF) AND UNDERWENT BALLOON KYPHOPLASTY (BKP) SURGERY. DURING SURGERY, WHEN THE SURGEON PUT THE BALLOON INTO VERTEBRAL BODY AND BEGAN INFLATING IT, THE BALLOON RUPTURED. NO FRAGMENTS OF THE ALLEGED BALLOON REMAINED IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8211242 ↗
• MalfunctionDec 31, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH VERTEBRAL COMPRESSION FRACTURES (VCF) AND UNDERWENT BALLOON KYPHOPLASTY (BKP) SURGERY. DURING SURGERY, THE BALLOON BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. A LITTLE CONTRAST MEDIA LEAKED INTO THE PATIENT'S BODY. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. NO FRAGMENTS OF THE BALLOON ARE REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8205749 ↗
• MalfunctionNov 6, 2018Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: INTRAVERTEBRAL CLEFTS LEVELS IMPLANTED: L3. IT WAS REPORTED THAT INTRA-OP, THE BALLOON BROKE WHILE EXPANDING AND THE CONTRAST MEDIUM LEAKED INTO THE VERTEBRAL BODY. THE CONTRAST MEDIA LEAKED ABOUT 1 CC. THE INSIDE OF THE VERTEBRAL BODY WAS WASHED AND SUCKED BY CATHETER. IT WAS CONFIRMED BY IMAGE THAT THERE WAS NO CONTRAST MEDIA REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8040826 ↗
• MalfunctionOct 17, 2018Material Rupture; Material Rupture

  PRE-OP DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE IT WAS REPORTED THAT INTRA-OP, THE INFLATION OF BALLOON WAS PERFORMED IN THE VERTEBRAL BODY AND THEN DEFLATION OF BALLOON WAS PERFORMED SUCCESSFULLY. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON, IT GOT STUCK AND COULD NOT BE REMOVED. AFTER DEFLATING THE BALLOON AGAIN, THE REMOVED BALLOON WAS FOUND TO BE BROKEN. NO FRAGMENTS REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7972984 ↗
• MalfunctionOct 16, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY (BKP) PROCEDURE. DURING SURGERY, THE BALLOON DID NOT INFLATE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7968586 ↗
• MalfunctionAug 30, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WAS PRESENTED WITH PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE. INTRA-OP, IBT RUPTURED DURING INFLATION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7831768 ↗
• MalfunctionAug 20, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH PRIMARY OSTEOPOROSIS AND UNDERWENT BALLOON KYPHOPLASTY (BKP) PROCEDURE AT L1 LEVEL. DURING SURGERY, THE BALLOON RUPTURED WHILE INFLATING. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE BALLOON REMAINED IN THE PATIENT. IT WAS CALCULATED THAT THERE WAS 3 ML OF THE CONTRAST MEDIA REMAINED IN THE PATIENT. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7796422 ↗
• MalfunctionAug 16, 2018Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE LEVELS OPERATED: T12 IT WAS REPORTED THAT INTRA-OP, DURING BALLOON INFLATION, ONE SIDE OF THE BALLOON RUPTURED AND THE CONTRAST MEDIA LEAKED OUT. THE CONTRAST MEDIA WAS SUCKED WITH SUCTION, AND A NEW BALLOON WAS OPENED FOR USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND CEMENT SOLIDIFICATION FINISHED WITHOUT ANY PROBLEM. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. NO COMPLICATIONS OR CONSEQUENCES WERE REPORTED TO THE PATIENT DURING THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7788290 ↗
• MalfunctionJul 20, 2018Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH OSTEOPOROSIS WITH SUBSEQUENT VERTEBRAL COMPRESSION FRACTURE AND UNDERWENT BALLOON KYPHOPLASTY. DURING SURGERY, THE IBT RUPTURED AT ABOUT 230 PSI. THEN, THE SURGEON USED ANOTHER BALLOON, OF SAME TYPE WITH THE PREVIOUS ON, FOR THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7705538 ↗
• MalfunctionJun 27, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY AT TH11 DUE TO PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE. INTRA-OP, THE CONTRAST MEDIUM LEAKED DURING INFLATING THE BALLOON OF THE LEFT SIDE. THE DEVICE CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7640501 ↗
• MalfunctionMay 23, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY (BKP). INTRA-OPERATIVELY, DURING INFLATION, THE INFLATABLE BONE TAMP(IBT) RUPTURED WHEN PRESSURE GAUGE DISPLAYED AS ABOUT 350. THE PATIENT WAS NOT ALLERGIC TO THE CONTRAST MEDIUM.THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7536075 ↗
• MalfunctionMay 16, 2018Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PRE-OP DIAGNOSIS, PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE. INTRA-OP, THE INFLATABLE BONE TAMP FAILED DURING THE FIRST INSERTION ATTEMPT INTO THE VERTEBRAL BODY. WHEN PRESSURE WAS APPLIED TO ONE PLACE WHILE INFLATING THE BALLOON, IT DEFORMED. THE BALLOON WAS PUT OUT OF THE BODY ONCE AND INFLATED, IT DID NOT INFLATE AS A WHOLE AND ONE PLACE OF THE BALLOON INFLATED LIKE BAKING A RICE CAKE. A 1 ML OF THE CONTRAST MEDIUM WAS ADDED TO THE BALLOON BUT THE BALLOON DID NOT INFLATE (PRESSURE 300PSI). THE CONTRAST MEDIUM WAS ADDED MORE AND WHEN 1.5 ML WAS PUT INTO THE BALLOON, THE BALLOON DEFORMED IN THE VERTEBRAL BODY AND ONLY A PART OF IT INFLATED (PRESSURE 380PSI). THE DEVICE CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. AFTER OCCURRENCE OF THE EVENT, A NEW KIT WAS OPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7517492 ↗
• MalfunctionMar 21, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE AT T12. INTRA-OP, WHILE PERFORMING THE SURGERY, IBT BALLOON ON THE RIGHT SIDE WAS FAILED TO DEFLECT USING THE HANDLE. ALTHOUGH BY TURNING THE HANDLE COUNTERCLOCKWISE THE SITUATION WAS SAME. NO FRAGMENTS REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7359027 ↗
• MalfunctionMar 7, 2018Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: VERTEBRAL BODY COMPRESSION FRACTURE IT WAS REPORTED THAT INTRA-OP, THE BALLOON BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7321075 ↗
• MalfunctionFeb 15, 2018Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT INTRA-OP, THE BALLOON RUPTURE DURING INFLATION. IT WAS DIFFICULT TO INSERT THE BALLOON INTO THE VERTEBRAL BODY. AFTER INSERTION, IT WAS CONFIRMED THAT THE LEAKAGE OF CONTRAST MEDIA OCCURRED DURING INFLATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7274816 ↗
• MalfunctionFeb 15, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY (BKP) AT L1 DUE TO PRIMARY OSTEOPOROSIS, COMPRESSION FRACTURE. DURING INFLATION, ONSE SIDE OF THE IBT (INFLATABLE BONE TAMP) RUPTURED. THE VOLUME AT THAT TIME WAS WAS 4 ML, AND CONTRAST MEDIA LEAKED. RIGHT BEFORE IT RUPTURED, THE INFLATION PRESSURE WAS UNKNOWN.THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. IT WAS WASHED WITH SALINE AND CONFIRMED WITH C-ARM. THE IBT WAS NOT REPLACED, AND THE OPERATION WAS PERFORMED CONTINUALLY AND COMPLETED. WHEN IT WAS FOUND THAT THERE WAS NO CONTRAST MEDIA , CEMENT WAS INJECTED. NO FRAGMENT OF THE BALLOON REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7272658 ↗
• MalfunctionJan 26, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY (BKP) DUE TO PRIMARY OSTEOPOROSIS, COMPRESSION FRACTURE. INTRA-OP, DURING INFLATION OF THE BALLOON IN THE VERTEBRAL BODY, THE IBT (INFLATABLE BONE TAMP) RUPTURED IN THE FIRST ATTEMPT. THE INCREASE OF DILATING PRESSURE STOPPED, AND THE LEAKAGE OF CONTRAST MEDIA OCCURRED. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIUM. A NEW ONE WAS NOT OPENED, AND THE OPERATION WAS COMPLETED WITH THE REPORTED DEVICE. NO FRAGMENT OF THE BALLOON REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7220979 ↗
• MalfunctionJan 11, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WAS PRESENTED WITH PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE, INTRA-OP, IBT RUPTURED DURING DEFLATION AND BONE CEMENT LEAKED FROM THE END PLATE. THE OPERATION OF EXTREME LATERAL INTERBODY FUSION AND POSTERIOR FUSION WAS PERFORMED. NO PATIENT COMPLICATIONS WERE REPORTED. PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7181537 ↗
• MalfunctionJan 9, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WAS PRESENTED WITH PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE AND WAS TREATED AT LEVEL TH12. DURING SURGERY, IBT RUPTURED DURING INFLATION. THERE WAS A BONE SPUR IN FRONT OF THE VERTEBRAL BODY. WHEN INFLATING THE BALLOON IN FRONT OF VERTEBRAL BODY, THE BALLOON TOUCHED WITH BONE SPUR AND RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7174348 ↗
• MalfunctionDec 28, 2017Material Rupture; Material Rupture

  PRE-OP DIAGNOSIS: VERTEBRAL COMPRESSION FRACTURE, IT WAS REPORTED THAT INTRA-OP THE BALLOON RUPTURED IN VERTEBRAL BODY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7150438 ↗

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-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-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-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