KYPHON Express II KyphoPak Tray KEX152EBRecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00763000026912), received between Aug 8, 2019 and Nov 14, 2025 — classified as 2 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (19 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 18, 2026.

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.

• MalfunctionNov 14, 2025Product Quality Problem; Material Deformation; Product Quality Problem; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY (L2) DUE TO PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE). IT WAS REPORTED THAT THE CONNECTOR ON THE IBT SIDE AND THE CONNECTION TO THE BALLOON WERE DEFORMED. THE SAME THING HAPPENED WHEN BE WAS USED PREVIOUSLY, SO IT IS CONSIDERED A PROBLEM WITH THE QUALITY OF THE PRODUCT. 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 23551956 ↗
• MalfunctionAug 28, 2025Product Quality Problem; Mechanical Jam; Product Quality Problem; Mechanical Jam

  INFORMATION WAS RECEIVED VIA HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT HAVING TRANSCUTANEOUS VERTEBROPLASTY FOR TH11 COMPRESSION FRACTURE. IT WAS REPORTED THAT WHEN ATTEMPTING TO REMOVE THE IBT STYLET, THERE IS A CREAKING SOUND AND IT WAS HARD THAT IT SEEMED LIKE IT COULD NOT BE ROTATED. THE PLIERS WERE TAKEN OUT AND ATTEMPTED TO REMOVE IT, BUT ONLY A PART COULD BE REMOVED AND THE STYLET COULD NOT BE REMOVED. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910373 ↗
• MalfunctionJul 30, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT BALLOON BROKE. PROCEDURE INVOLVED WAS BALLOON KYPHO PLASTY. NO PATIENT SYMPTOMS DUE TO THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663212 ↗
• MalfunctionJun 3, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY WITH PERCUTANEOUS POSTERIOR FUSION THERAPY AT L1. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS PRIMARY OSTEOPOROSIS FOR RUPTURE FRACTURE. IT WAS REPORTED THAT DURING INITIAL INSERTION INTO THE VERTEBRAL BODY, THE BALLOON ON ONE SIDE WAS RUPTURED WHEN IT WAS INF LATED TO ABOUT 3 ML AFTER EXPANSION. 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 22129670 ↗
• MalfunctionMay 20, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L1 BALLOON KYPH OPLASTY (BKP) FOR AN INDICATION OF PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE - INTRASPINE CLEFT). IT WAS REPORTED THAT THE BALLOON WAS DAMAGED (RUPTURED) DURING EXPANSION. THERE WAS A DELAY OF LESS THAN 60 MINS REPORTED. 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 22050586 ↗
• MalfunctionApr 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE L3 RIGHT BALLOON WAS BROKEN, AND THE LEFT SIDE WAS ALSO FOUND TO BE BROKEN. RE-EXPAND WITH ADDITIONAL PRODUCT, BUT STILL, THE RIGHT SIDE WAS ALSO BROKEN. THERE WAS NO PROBLEM WITH THE LEFT SIDE. TYPE OF FRACTURE: COMPRESSION FRACTURE. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING A NEW PRODUCT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE BALLOON WAS BROKEN INSIDE THE PATIENT AND THEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21760505 ↗
• MalfunctionApr 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE L3 RIGHT BALLOON WAS BROKEN, AND THE LEFT SIDE WAS ALSO FOUND TO BE BROKEN. RE-EXPAND WITH ADDITIONAL PRODUCT, BUT STILL, THE RIGHT SIDE WAS ALSO BROKEN. THERE WAS NO PROBLEM WITH THE LEFT SIDE. TYPE OF FRACTURE: COMPRESSION FRACTURE. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING A NEW PRODUCT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE BALLOON WAS BROKEN INSIDE THE PATIENT AND THEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21760465 ↗
• MalfunctionApr 1, 2025Difficult to Insert; Difficult to Insert

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PERCUTANEOUS VE RTEBRAL BODY DEVELOPMENT BRIDGE FOR COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE INFLATABLE BALLOON TAMP COULD NOT BE INSERTED INTO THE OSTEO-INTRODUCER. A SEPARATE KIT WAS UNBOXED AND THEN INSERTED AND SURGERY WAS COMPLETED.  THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. 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 21736709 ↗
• MalfunctionMar 28, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING 3RD LUMBAR VERT EBRA TRANSCUTANEOUS VERTEBROPLASTY FOR AN INDICATION OF PRIMARY OSTEOPOROSIS. TYPE OF FRACTURE: COMPRESSION FRACTURE, RUPTURE FRACTURE AND INTRASPINAL CLEFT. IT WAS REPORTED THAT THE IBT WAS RUPTURED WHILE INFLATING. 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 21716662 ↗
• MalfunctionFeb 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED TRANSCUTANEOUS VERTEBROPLASTY THERAPY FOR THE PRIMARY OSTEOPOROSIS. TYPE OF FRACTURE COMPRESSION, INTRASPINAL CLEFT. LEVELS IMPLANTED WERE L1. IT WAS REPORTED THAT FOLLOWING THE PROCEDURE MANUAL, AFTER PLACING BALLOONS ON BOTH SIDES, THE LEFT SIDE HAD A HIGH PRESSURE, BUT CAREFUL INFLATION ALLOWED FOR APPROXIMATELY 3CC OF EXPANSION WITHOUT ISSUES. ON THE RIGHT SIDE, THE PRESSURE INCREASED AFTER ABOUT 2CC OF FILLING. AS IT WAS SLOWLY ROTATED, THE PRESSURE SUDDENLY DROPPED FROM AROUND 300 TO A ZERO READING. THE FLUOROSCOPY VIDEO, THOUGH OBSCURED BY THE CONTRAST AGENT ON THE LEFT, CONFIRMED THAT THE RIGHT BALLOON HAD BURST, RELEASING CONTRAST AGENT. BOTH BALLOONS WERE IMMEDIATELY REMOVED, AND THE AREA WITHIN THE VERTEBRA WAS THOROUGHLY IRRIGATED MULTIPLE TIMES UNTIL THE CONTRAST AGENT WAS NO LONGER VISIBLE. SUBSEQUENTLY, BASED ON THE DOCTOR'S DECISION, CEMENT WAS FILLED, AND THE PROCEDURE CONCLUDED SUCCESSFULLY, APART FROM THE BALLOON RUPTURE. 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 21352603 ↗
• MalfunctionJan 17, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY (BKP) THERAPY FOR PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE). LEVELS IMPLANTED AT L2. IT WAS REPORTED THAT WHEN THE BALLOON WAS INFLATED TO AROUND 3 CC (APPROXIMATELY 350 PSI), THE PSI DISPLAY BECAME 0; UPON CHECKING WITH THE ARM, IT WAS CONFIRMED THAT IT HAD CONTRACTED. THE RUPTURE OCCURRED DURING EXPANSION. 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 21176410 ↗
• MalfunctionJan 13, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L1 BALLOON KYPH OPLASTY (BKP) FOR AN INDICATION OF PRIMARY OSTEOPOROSIS - COMPRESSION FRACTURE. IT WAS REPORTED THAT THE IBT WAS RUPTURED DURING BALLOON EXPANSION. 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 21136321 ↗
• MalfunctionJan 3, 2025Break; 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 (BKP) SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT BOTH BALLOONS WERE BROKEN. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT IT WAS CLEANED WITH SALINE SOLUTION AND THERE SEEMS TO BE NO FRAGMENTS WHEN VIEWED FROM THE RUPTURED BALLOON. IT WAS USED ON THE PATIENT. AFTER IT WAS DAMAGED, IT WAS REMOVED AND FILLED WITH CEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066605 ↗
• MalfunctionJan 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE L3 RIGHT BALLOON WAS BROKEN, AND THE LEFT SIDE WAS ALSO FOUND TO BE BROKEN. RE-EXPAND WITH ADDITIONAL PRODUCT, BUT STILL, THE RIGHT SIDE WAS ALSO BROKEN. THERE WAS NO PROBLEM WITH THE LEFT SIDE. TYPE OF FRACTURE: COMPRESSION FRACTURE. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING A NEW PRODUCT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE BALLOON WAS BROKEN INSIDE THE PATIENT AND THEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066499 ↗
• MalfunctionDec 31, 2024Break; Material Rupture; Break; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN B ALLOON KYPHOPLASTY SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE BALLOON WAS EXPANDED SMOOTHLY, AND THE PSI DECREASED DURING CEMENT MIXING. WHEN THE IMAGE WAS CHECKED, IT WAS CONFIRMED THAT THE BALLOON WAS BROKEN INTO TWO EQUAL PARTS EXACTLY AT THE CENTER OF THE FRONT AND BACK. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPR ESENTATIVE THAT THE BALLOON WAS RUPTURED. THERE ARE NO BROKEN FRAGMENTS OF BALLOON LEFT INSIDE THE PATIENT. THERE WERE NO PROBLEMS AT FIRST AND EVEN THOUGH THE BALLOON WAS INFLATED, IT RUPTURED HALFWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21046074 ↗
• MalfunctionDec 30, 2024Difficult to Insert; Difficult to Insert

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSCUTANEOUS VERTEBRAL ANGIOPLASTY SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE). LEVELS IMPLANTED AT L1. IT WAS REPORTED THAT WHEN INSERTING THE OSTEO INTRODUCER AND DRILLING, A STRANGE FEELING WAS FELT (SOMETHING SEEMED TO GET CAUGHT A BIT) THAT WAS DIFFERENT FROM USUAL, SO WHEN THE INNER CYLINDER OF THE INTRODUCER WAS CHECKED, A PIECE OF METAL (BURR) WAS FOUND. 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 21033568 ↗
• MalfunctionDec 28, 2024Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGOING SPINE SURGERY FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT INSTRUMENT WAS HARD AND COULD NOT BE PULLED OUT. NO PATIENT SYMPTOMS REPORTED. NO TREATMENT OR ADDITIONAL SURGERY WAS PERFORMED. THERE WAS DELAY OF LESS THAN 60 MINUTES DUE TO THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21031572 ↗
• MalfunctionDec 28, 2024Material Rupture; Mechanical Jam; Material Rupture; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY AT L4 FOR COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE BALLOON RUPTURED DURING INFLATION. THE BALLOON WAS REMOVED AND SALINE SOLUTION WAS INJECTED THROUGH THE CANNULA AND THEN ASPIRATED REPEATEDLY. AFTER THE INITIAL INSERTION, THE BALLOON WAS INFLATED, DEFLATED, AND THEN REMOVED, AND INSERTION WAS TRIED AGAIN, BUT IT WAS STUCK IN THE CANNULA AND DID NOT ADVANCE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMTION RECEIVED. THE BALLOON ON ONE SIDE BROKE DURING INFLATION (APPROXIMATELY 2.5 CC). AS SUCH, THE BROKEN ONE WAS REMOVED, AND THE BALLOON ON THE C ONTRALATERAL SIDE WAS DEFLATED AND REMOVED. RE-INSERTION WAS ATTEMPTED ON THE BROKEN SIDE BUT COULD NOT BE INSERTED. SINCE IT HAD EXPANDED TO ABOUT 2.5 CC, INSERTION WAS ABANDONED AND CEMENT WAS INJECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21031571 ↗
• MalfunctionNov 27, 2024Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT USED IN BALLOON KYPHOPLASTY FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE BALLOON COULD NOT PASS THROUGH THE OUTER TUBE OF THE OSTEOINTRODUCER. THERE IS A IRRELEVANT PATIENT SYMPTOM PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) REPORTED WHICH NOT DUE TO REPORTED PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20793392 ↗
• MalfunctionNov 26, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. LEVELS IMPLANTED WAS T12. IT WAS REPORTED THAT THE BALLOON INFLATED INSIDE THE VERTEBRAL BODY, THEN DEFLATED AND COULD NOT BE REINSERTED AS THE BALLOON WAS BROKEN. THE MIXER AND CEMENT WERE DISPOSED OF BECAUSE THE CEMENT HAD HARDENED DUE TO INSERTION TO THE BFD. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE BALLOON COULD NOT BE REINSERTED DUE TO BENDING OF THE OSTEO INTRODUCER. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE ARE NO ALLEGED COMPLAINTS FOR THE REPORTED MIXER AND AS THE BALLOON COULD NOT BE INSERTED DUE TO BENT INTRODUCER THE CEMENT THAT HAD ALREADY BEEN PREPARED HARDENED OVER TIME. THERE ARE NO ALLEGED COMPLAINTS FOR THE CEMENT AND BALLOON WAS BROKEN. NO SUSPECTED MANUFACTURING ISSUES HAVE BEEN REPORTED AND NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784019 ↗
• MalfunctionNov 18, 2024Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY (BKP) FOR AN INDICATION OF PRIMARY OSTEOPOROSIS COMPRESSION FRACTURE. IT WAS REPORTED THAT THE BALLOON WAS RUPTURED DURING INFLATION AT 300PSI. 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 20705388 ↗
• MalfunctionOct 9, 2024Difficult to Insert; Difficult to Insert

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3 POSTERIOR CE RVICAL DECOMPRESSION FUSION FOR AN INDICATION OF PRIMARY OSTEOPOROSIS COMPRESSION FRACTURE. IT WAS REPORTED THAT THE BALLOON WAS INFLATED AND DEFLATED, THEN THE TRACK WAS CHANGED AND THE PATH WAS CREATED AGAIN; WHEN AN ATTEMPT WAS MADE TO RE-INSTALL THE BALLOON, THE IBT COULD NOT PASS THROUGH THE OSTEOINTRODUCER (CANNULA). 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 20405933 ↗
• MalfunctionOct 3, 2024Product Quality Problem; Material Rupture; Use of Device Problem; Mechanical Jam; Product Quality Problem; Material Rupture; Use of Device Problem; Mechanical Jam

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCTS THAT IS USED IN BALLOON KYPHOPLASTY (BKP) SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS (TYPE OF FRACTURE WAS COMPRESSION FRACTURE). LEVELS IMPLANTED WAS L1. IT WAS REPORTED THAT WHEN SURGEON TRIED TO PULL OUT THE MIDDLE AXIS WHILE TRYING THROUGH THE FRONT IMAGE, IT WAS TOO HARD AND COULD NOT BE PULLED OUT, THEN OBSERVED THAT THERE WAS HOLE AT THE TIP OF THE BALLOON. THERE WAS A RUPTURE OBSERVED DURING EXPANSION. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20356841 ↗
• MalfunctionSep 20, 2024Break; Mechanical Jam; Break; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS PRIMARY OSTEOPOROSIS FOR COMPRESSION FRACTURE. IT WAS REPORTED THAT  DURING EXPANSION, IBT WAS INFLATED AND WHEN IT WAS TRIED TO TAKE OUT THE STYLET, IT COULD NOT BE TAKEN OUT; WHEN IT WAS TRIED TO PULL IT OUT AGAIN, THE BALLOON WAS BROKEN. 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 20265041 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN TRANSCUTANEOUS VERTEBROPLASTY. IT WAS REPORTED THAT WHEN OSTEO INTRODUCER WAS INSERTED INTO THE AORTA, IT GOT STUCK IN AORTA AND BLEEDING HAPPENED. THE PROCEDURE WAS DISCONTINUED AND ADDITIONALLY VASCULAR REPAIR WAS PERFORMED BY VASCULAR SURGEON. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT DURING THE INSERTION OF THE INTRODUCER, IT PUNCTURED THE ANTERIOR PORTION OF THE LEFT L1 VERTEBRAL BODY. HEMORRHAGING WAS OBSERVED THROUGH THE CANNULA, SO A VASCULAR SURGEON USED A COIL TO PERFORM COMPRESSION HEMOSTASIS AND HEMOSTASIS. IN ORDER TO CHECK THE STATE OF THE DAMAGE, THEY WERE PLACED IN A SUPINE POSITION AND LAPAROTOMY WAS PERFORMED; HOWEVER, THERE WAS NO DAMAGE TO THE AORTA AND HEMOSTASIS WAS PERFORMED, SO THE WOUND CLOSURE/SURGICAL INCISION CLOSURE WITHOUT ANY FURTHER ACTION. AS A RESULT, THE BRANCHING VESSELS WERE DAMAGED, NOT THE AORTA. THERE WAS NO HUMAN FACTORS OR NO DEVICE MALFUNCTION AS THE CAUSE OF VASCULAR DAMAGE. THE CONDITION IS CURRENTLY IMPROVING AND REVISION SURGERY (BKP) IS

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Spinal Column Injury

  MAUDE report 19747892 ↗