CONFIDENCE SPINAL CEMENT SYSTEM 283903413Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034209463), received between Oct 17, 2017 and Jan 13, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE PATIENT HAS A FRACTURE OF THE FIRST LUMBAR VERTEBRA (L1) AND REQUIRES SURGERY FOR BONE CEMENT AUGMENTATION AND INTERNAL FIXATION AT T12 AND L2, USING THE CONFIDENCE SPINAL CEMENT SYSTEM. DURING THE CEMENT INJECTION PROCEDURE AT L1, THE INTRODUCER NEEDLE BROKE DUE TO THE HARDNESS OF THE LEFT SIDE OF THE L1 VERTEBRAL BODY, AND A PORTION OF THE METAL CANNULA BECAME EMBEDDED IN THE BONE AND COULD NOT BE REMOVED. THE BONE CEMENT INJECTION WAS NOT CONDUCTED AT L1 BUT STILL CARRIED OUT AT T12 AND L2. POST-SURGERY, AN X-RAY EXAMINATION WAS PERFORMED, AND THE PATIENT HAS BEEN RETURNED TO THE WARD FOR CONTINUED OBSERVATION. CURRENTLY, THE PATIENT'S CONDITION IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21139939 ↗
• MalfunctionMar 22, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ISRAEL AS FOLLOWS: IT WAS REPORTED ON MARCH, 8, 2024 THAT THE PATIENT, 72 YEARS OLD, ARRIVED TO UNDERGO A THORACIC SPINE FIXATION SURGERY BETWEEN THE T5 AND T7 VERTEBRAE. THE SURGEON CHOSE TO USE THE CONFIDENCE INTRODUCER NEEDLE DIAMOND TIP (HEREAFTER: THE "NEEDLE") TO ENTER THE VERTEBRAL BODY THROUGH THE PEDICLE. THE PROCEDURE IS PERFORMED BY USING A HAMMER TO INSERT THE NEEDLE. IN THE FIRST STAGE, A NEEDLE WAS INSERTED THROUGH THE PEDICLE INTO THE T7 VERTEBRA, THE NEEDLE WAS BENT AND THE SURGEON PULLED IT OUT AND INSERTED ANOTHER NEEDLE FROM THE SAME SKU IN ITS STEAD AND MANAGED TO ENTER THE BODY OF THE VERTEBRA. THE SURGEON THEN MADE AN ENTRY THROUGH THE PEDICLE TO THE T5 VERTEBRA USING ANOTHER NEEDLE FROM THIS SKU. THE NEEDLE WAS BENT AND THE SURGEON PULLED IT OUT AND INSERTED ANOTHER NEEDLE FROM THE SAME SKU IN ITS STEAD, AND MANAGED TO ENTER THE BODY OF THE VERTEBRA. IN THE T5 VERTEBRA, THE SURGEON CONTINUED THE PROCEDURE BY REMOVING THE INNER LUMEN OF THE NEEDLE AND INSERTED A GUIDE WIRE THROUGH THE NEEDLE SLEEVE CHANNEL. AFTER PLACING THE GUIDE WIRE, THE SURGEON TRIED TO REMOVE THE NEEDLE SLEEVE FROM THE VERTEBRA, BUT WAS UNABL

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961032 ↗
• MalfunctionSep 14, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ISRAEL AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT DURING AN OPERATION THEY INJECT CEMENT INTO THE PATIENT'S VERTEBRAL BODY - KYPHOPLASTY, THE INJECTION NEEDLE BROKE INSIDE THE PATIENT'S VERTEBRAL BODY FOLLOWING THIS, THE SURGEON HAD TO MAKE AN INCISION IN THE PATIENT'S SKIN TO REMOVE THE BROKEN PART INSIDE THE VERTEBRA - THE REMOVAL WAS PERFORMED SUCCESSFULLY. THE SURGERY WAS DELAYED FOR 30 MINUTES DUE TO THE REPORTED EVENT. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) CONF INTRO NDLE, DIA, 13G 4" THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744944 ↗
• MalfunctionSep 28, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT WHEN TRYING TO PULL THE NEEDLE OUT OF THE SHAFT, THE NEEDLE BROKE AT THE CONNECTION TO THE UPPER PLASTIC PART. THE DOCTOR BROKE OFF THE REST OF THE NEEDLE WITH HIS HAND. HE DECIDED THAT THE PART OF THE NEEDLE THAT WAS LEFT IN THE SHAFT WOULD NOT BE REMOVED BECAUSE HE DID NOT WANT TO DAMAGE THE SHAFT. THE DELAY WAS LESS THAN 30 MINUTES. THE SAME PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT. PATIENT STATUS/ OUTCOME: GOOD THIS REPORT IS FOR ONE (1) CONF INTRO NDLE, DIA, 13G 4" THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15500965 ↗
• MalfunctionSep 26, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE NEEDLE WOULD NOT COME OUT AFTER THE APPLICATION OF CEMENT. THE SURGEON TRIED TO REMOVE IT BY HIMSELF, AND THE NEEDLE BROKE. THE BROKEN FRAGMENT WAS TAKEN OUT THROUGH THE LAMINECTOMY INCISION. AN X-RAY WAS PERFORMED, AND NO FRAGMENTS WERE SEEN IN THE VERTEBRA. THE PATIENT HAD A METASTATIC TUMOR ON THE SPINE WITH HARD BONE. THE SURGEON PASSED THE NEEDLE UNTIL THE MIDDLE OF THE VERTEBRAL BODY AND COULD NOT ADVANCE IT ANY FURTHER, SO HE DECIDED TO INJECT CONFIDENCE SPINAL CEMENT. SURGERY WAS DELAYED BECAUSE THEY HAD TO PASS OTHER EQUIPMENT TO BE ABLE TO REMOVE THE FRAGMENT. THIS REPORT INVOLVES ONE CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 13G X 4 INCHES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15487261 ↗
• InjuryMay 5, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A KYPHOPLASTY PROCEDURE, TWO NEEDLES WERE INSERTED INTO THE PATIENT'S VERTEBRAE (BI-LATERAL APPROACH). AFTER INSERTING THE NEEDLES, THE SURGEON DECIDED TO SWITCH THE NEEDLES TO THE ONES IN THE SYNFLATE KIT IN ORDER TO USE A BALLOON. THE NEEDLES GOT STUCK IN THE PATIENT'S VERTEBRAE AND A LOT OF FORCE WAS USED TO TRY TO GET THEM OUT. ONE (1) NEEDLE CAME OUT AND THE OTHER ONE (1) DETACHED FROM THE HANDLE BECAUSE OF THE FORCE THAT WAS USED. WHILE PULLING THE NEEDLE OUT IT BROKE AND AN OPEN PROCEDURE NEEDED TO BE PERFORMED. AFTER PREFORMING A SMALL INCISION, THE SURGEON REACHED THE BASE OF THE VERTEBRAE AND PULLED WHATEVER HE COULD FROM THE NEEDLE. A PART OF THE NEEDLE REMAINED IN THE VERTEBRAE. IN ADDITION, AFTER INSERTING THE SYNFLATE'S BALLOON AND INFLATING IT, THE BALLOON RIPPED AND FAILED UNDER THE PRESSURE (ALTHOUGH THE BAR DIDN'T REACH THE MAXIMUM LEVEL PERMITTED). THERE WAS A SURGICAL DELAY OF ONE (1) HOUR. THIS REPORT IS FOR ONE (1) CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 13G X 4 INCHES. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4).

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 11776932 ↗
• MalfunctionJul 11, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A VERTEBRAL BODY AUGMENTATION (VBA) PROCEDURE, THE SURGEON ENCOUNTERED A SCLEROTIC BONE WHICH MADE IT VERY DIFFICULT TO PULL OUT THE INTRODUCER NEEDLE. DURING HIS ATTEMPTS TO PULL IT OUT OF THE VERTEBRAE, THE NEEDLE BROKE FROM ITS HANDLE. HE LATER SUCCEEDED TO PULL OUT THE NEEDLE ITSELF FROM THE PATIENT AND THE PATIENT WAS NOT HARMED. SURGICAL DELAY AND PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8781592 ↗
• InjuryJun 4, 2019Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE THE TIP BROKE OFF AT THE BEGINNING OF THE PEDICLE WHILE INSERTING THE NEEDLE WITHOUT INITIATED EXCESSIVE FORCE. IT IS UNKNOWN IF THERE WAS NO SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8668274 ↗
• MalfunctionOct 17, 2017Break; Break

  NEEDLE BROKE OFF INTRAOPERATIVELY, PARTS REMAIN IN PATIENT. LAWYER IS ASKING FOR TECHNIQUE GUIDE AND IF THE MATERIAL REMAINED IN PATIENT COULD THIS LEAD TO A PATIENT HARM?

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6954311 ↗