CONFIDENCE SPINAL CEMENT SYSTEM 283903611Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705034209494), received between Jun 15, 2018 and Jan 30, 2025 — classified as 10 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON PERFORMING AN L5-S1 FUSION, WANTED TO USE JAMSHEDI/PROBE TO TAP INTO BONE BEFORE PLACING A GUIDEWIRE OVER WHICH HE WOULD PLACE CORTICAL FIX SCREW. HOSPITAL HAD NONE OF THEIR USUAL KITS AS THEY ARE NOW DISCONTINUED, SO NOW THE ONLY OPTION WAS TO USE THE JAMSHEDI/PROBE. SURGEON USED TOFFEE HAMMER TO TAP IN THE CANNULA, THE T-HANDLE AT TOP OF CANNULA SNAPPED OFF SO REMOVED THE INNER PART TO PLACE GUIDEWIRE. THE OUTER TUBE OF CANNULA COULD THEN NOT BE REMOVED AND WAS CRUSHED WHEN USING A ¿BONE NIBBLER¿ TO TRY AND PULL IT OUT. SURGEON WAS SNAPPING OFF SMALL PARTS IN AN ATTEMPT TO REMOVE IT. THE TUBE WAS TOO CRUSHED TO PASS THE INNER PART BACK DOWN TO GIVE IT SOME RIGIDITY. AFTER A FURTHER 40 MINUTES AND THE ASSISTANCE OF A BURR, THE SURGEON WAS ABLE TO DRILL DOWN THE SIDE OF THE BROKEN PIECE AND REMOVE THE LAST BIT OF CANNULA. SCRUB TEAM AND SALES REPRESENTATIVE CONFIRMED THAT IT WAS THE FULL TIP AS COMPARED SIDE BY SIDE TO ANOTHER CANNULA. AN ADDITIONAL HOUR WAS ADDED TO THE CASE DUE TO THE EVENT. HOSPITAL HAS SINCE SOURCED NEW REPLACEMENT OF THEIR DISPOSABLE PROBES. THEY HAVE ALSO ADDED VIPER 2 CANNULATED PEDICLE PROBES WITH STYLETS TO HAVE THE REUSABL

  Patient problems: Insufficient Information

  MAUDE report 21274947 ↗
• InjuryJul 26, 2023Break; Break

  THERE WERE NO ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT. PATIENT IS OK.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17398008 ↗
• InjuryApr 25, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT A PPS PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, THE CONFIDENCE NEEDLE BROKE WHEN IT WAS INSERTED INTO A VERTEBRA. THE SURGEON FELT SOMETHING WRONG WITH TAPPING AND CHECKED THE AFFECTED AREA BY IMAGE INTENSIFIER. A FRAGMENT OF THE BROKEN CONFIDENCE NEEDLE WAS OBSERVED. THE SURGEON DECIDED TO LEAVE THE FRAGMENT IN THE PATIENT¿S BODY, AS IT WAS CONSIDERED RISKIER TO REMOVE THE FRAGMENT. ABOUT 2 CM OF THE BROKEN CONFIDENCE NEEDLE REMAINED IN THE PATIENT¿S BODY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT WAS STABLE. THE SURGEON STATED THAT THE PATIENT'S VERTEBRA WAS HARD. THIS REPORT IS FOR A CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 11G X 6 INCHES.

  Patient problems: Foreign Body In Patient

  MAUDE report 16811237 ↗
• InjuryJun 3, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE CONFIDENCE 11G NEEDLE TIP BROKE OFF IN THE PEDICLE DURING MIS SURGERY AND THE TIP WAS UNABLE TO BE REMOVED. THE SURGEON PLACED A SCREW BEHIND THE BROKEN TIP AND IS COMFORTABLE THAT THE TIP WILL NOT MOVE OR CAUSE INJURY TO THE PATIENT. THERE WAS A SURGICAL DELAY OF 10 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE CONF INTRO NDLE, DIA, 11G 6". THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 14595244 ↗
• MalfunctionJan 20, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PERCUTANEOUS PROCEDURE, AFTER CENTERING THE PEDICLE WITH THE TROCAR AND INSERTING THE KIRSHNER WIRE, THE DOCTOR WAS UNABLE TO REMOVE THE OUTER PART OF THE TROCAR. AFTER REPEATED ATTEMPTS TO REMOVE THE TROCAR, IT BROKE. A METAL PART REMAINED ATTACHED TO THE HANDLE THAT THE SURGEON FOUND IN HIS HAND, A SECOND PART CAME OFF WITH THE USE OF A FORCEPS AND A LAST PART REMAINED INSIDE THE VERTEBRAL PEDUNCLE. THE DOCTOR HAD TO SWITCH FROM A PERCUTANEOUS PROCEDURE TO AN OPEN PROCEDURE. TO REMOVE WHAT WAS IN THE BONE HE HAD TO WORK WITH A MOTORIZED BUR AND REMOVE THE FRAGMENTS THAT WERE GRADUALLY BEING CREATED. THERE WAS A TWO (2) HOUR SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES ONE (1) CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 11G X 6 INCHES. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13308168 ↗
• MalfunctionJan 20, 2022Break; Material Deformation; Break; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A LUMBAR ARTHRODESIS FIXATION SURGERY, THE CONFIDENCE SPINAL CEMENT NEEDLE BROKE. PART OF THE NEEDLE REMAINED INSIDE THE BONE (VERTEBRA) WITHOUT CAUSING DAMAGE OR INJURY. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 11G X 6 INCHES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306761 ↗
• InjuryOct 22, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE NEEDLE BROKE IN THE BONE OF THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT ACCESS IN THE PEDICLE IN ORDER TO INTRODUCE THE SCREW. THERE WAS A SURGICAL DELAY. THIS REPORT IS FOR (1) CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 11G X 6 INCHES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12682701 ↗
• MalfunctionAug 24, 2021Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: THE SURGEON WAS PERFORMING A L4-S1 ALIF + MIS INSTRUMENTED FUSION ON PATIENT ON THE (B)(6) 2021. WHILE INSERTING A CONFIDENCE NEEDLE TO ASSIST WITH THE GUIDING OF THE SACRAL ALAR ILIAC SCREW (SAI), A GUIDEWIRE WAS PLACED DOWN THE CONFIDENCE NEEDLE BUT UPON REMOVING THE NEEDLE IT WAS NOTED THAT A LARGE SECTION OF THE NEEDLE HAD BROKEN OFF AND REMAINED IN THE PATIENT. A SECOND NEEDLE WAS USED TO PLACE THE SAI SCREW AND WHEN THE GUIDEWIRE WAS REMOVED FROM THE FIRST ATTEMPT THE BROKEN SECTION REMOVED WITH THE GUIDEWIRE. THE SURGEON WAS SATISFIED THAT NO FRAGMENTS REMAINED. THIS REPORT IS FOR A CONFIDENCE NEEDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12357919 ↗
• InjuryApr 13, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, TWO INTRODUCER NEEDLES BROKE INTRAOPERATIVELY DURING STABILIZATION OF LUMBAR VERTEBRAE 3 TO 5. THE NEEDLE WAS BROUGHT INTO THE PEDICLE, THEN THE INSIDES OF THE PEDICLE WERE TAKEN OUT AND A VIPER 2 GUIDEWIRE WAS INSERTED. DURING THE UNSCREWING OF THE OUTER SLEEVE OF THE NEEDLE, A CRACK WAS HEARD AND THE SLEEVE BROKE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 11G X 6 INCHES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11657195 ↗
• InjuryApr 13, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, TWO INTRODUCER NEEDLES BROKE INTRAOPERATIVELY DURING STABILIZATION OF LUMBAR VERTEBRAE 3 TO 5. THE NEEDLE WAS BROUGHT INTO THE PEDICLE, THEN THE INSIDES OF THE PEDICLE WERE TAKEN OUT AND A VIPER 2 GUIDEWIRE WAS INSERTED. DURING THE UNSCREWING OF THE OUTER SLEEVE OF THE NEEDLE, A CRACK WAS HEARD AND THE SLEEVE BROKE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 11G X 6 INCHES. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11657170 ↗
• InjuryDec 14, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING THE REMOVAL OF THE CONFIDENCE INTRODUCER NEEDLE FROM THE SCLEROTIC BONE, THE HANDLE BROKE OFF, WHICH LEFT THE NEEDLE IN-SITU. THE NEEDLE WAS REMOVED BY INCREASING THE EXPOSURE OF TISSUE. FRAGMENTS WERE GENERATED AND REMOVED EASILY. THERE WAS A SURGICAL DELAY OF FIVE (5) TO TEN (10) MINUTES. AN X-RAY WAS TAKEN TO CONFIRM THAT NO FRAGMENTS WERE LEFT IN-SITU. THERE WAS NO REPORTED CONSEQUENCE TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 11G X 6 INCHES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11002658 ↗
• MalfunctionJun 23, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A PERCUTANEOUS PEDICLE SCREW FIXATION, THE CONFIDENCE NEEDLE WAS USED WITH ANOTHER UNKNOWN MANUFACTURE SYSTEM. THE T-SHAPED COMPONENT BROKE AND CAME OFF THE UNIT WHILE IN USE. THE PROCEDURE WAS DELAYED FOR THIRTY (30) MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 11G X 6 INCHES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10184951 ↗
• InjuryNov 11, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A VERTEBROPLASTY SURGERY WITH THE CONFIDENCE SYSTEM ON (B)(6) 2019, WHEN THE NEEDLES WERE REMOVED EIGHT (8) MINUTES AFTER MIXING, ONE OF THEM BROKE AT THE PEDICLE AND THE FRAGMENT WAS NOT RECOVERED. TWO NEEDLES OF DIFFERENT LOT WERE USED. THE SURGEON REPORTED THAT THERE IS NO PROBLEM BUT OBSERVED THE WEAKNESS OF THE CANNULAS TO DENSE BONE ROTATION, SINCE THESE WERE INSERTED WITH A LOT OF IMPACT. THIS REPORT IS FOR A CONFIDENCE INTRODUCER NEEDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9305512 ↗
• InjurySep 26, 2019Break; Break

  I ATTEND VERTEBROPLASTY SURGERY WITH THE CONFIDENCE SYSTEM. WHEN THE NEEDLES REFERENCES 283903611 WERE REMOVED, AFTER 8 MIN AFTER MIXING, ONE OF THEM FRACTURES AT THE RATE OF THE PEDICLE AND THE FRAGMENT WAS NOT RECOVERED. SURGEON REPORTS THAT THERE IS NO PROBLEM BUT OBSERVED THE WEAKNESS OF THE CANNULAS TO DENSE BONE ROTATION, SINCE THESE WERE INSERTED WITH A LOT OF IMPACT. TWO NEEDLES OF DIFFERENT LOT WERE USED AND WERE NOT MARKED, I RETURN BOTH AND THEIR BOXES. ATTACHED PHOTO OF HOW IT IS IN THE PEDICLE AND THE BOXES THAT REMAIN IN CONTAINER. PROCEDURE: VERTEBROPLASTY. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9124011 ↗
• InjuryOct 4, 2018Break; Break

  IT WAS REPORTED THAT THE REPORTED DEVISE WAS USED TO ILIAC TO CREATE THE BONE HOLE FOR THE INVASIVE OSTEOSYNTHESIS ON (B)(6) 2018. DURING THE SURGERY, THE SURGEON FELT DIFFICULTY TO REMOVE THE CANNULA FROM THE PATIENT¿S BONE HOLE WHEN THE SURGEON REMOVED THE CANNULA AFTER PASSED THE GUIDE WIRE. THE SURGEON USED THE HUMMER TO REMOVE THE CANNULA, BUT THE SURGEON COULD NOT REMOVE. THEN, THE SURGEON USED THE PLIERS, HOWEVER, THE CANNULA WAS BROKEN AND REMAINED IN THE PATIENT¿S BONE. THE SURGEON DECIDED TO KEEP THE BROKEN FRAGMENT INTO THE PATIENT¿S BODY, AND WILL BE REMOVED FROM THE PATIENT¿S BODY DURING THE SCHEDULED SURGERY (2 OR 3 MONTH LATER, SURGERY DATE IS NOT FIXED YET). HERE WAS 60 MIN. SURGICAL DELAY. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Foreign Body In Patient; Not Applicable

  MAUDE report 7935027 ↗
• MalfunctionJun 15, 2018Break; Break

  TWO SEPARATE SHAFTS OF INTRODUCER NEEDLES BROKE OFF INSIDE THE PATIENTS BILATERAL PEDICLES. THE INTRODUCER NEEDLE JUST CRUMPLED AND FURTHER BROKE APART WHEN THE SURGEON TRIED TO DISLODGE THE BROKEN PIECES FROM THE PATIENTS SPINE (BILATERAL L5 PEDICLES).

  Patient problems: Local Reaction

  MAUDE report 7606870 ↗
• MalfunctionJun 15, 2018Break; Break

  TWO SEPARATE SHAFTS OF INTRODUCER NEEDLES BROKE OFF INSIDE THE PATIENTS BILATERAL PEDICLES. THE INTRODUCER NEEDLE JUST CRUMPLED AND FURTHER BROKE APART WHEN THE SURGEON TRIED TO DISLODGE THE BROKEN PIECES FROM THE PATIENTS SPINE (BILATERAL L5 PEDICLES).

  Patient problems: Local Reaction

  MAUDE report 7606779 ↗