CONFIDENCE SPINAL CEMENT SYSTEM 283903411Recalls & reported problems
Medos International Sàrl · CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 11G x 4 Inches · Class 1
All models of CONFIDENCE SPINAL CEMENT SYSTEM (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705034209456), received between Feb 12, 2018 and Jun 17, 2025 — classified as 7 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Break” (15 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.
Reports received per month
Most reported problems
Device problems
- Break15
- Entrapment of Device9
- Material Deformation2
- Material Fragmentation1
Patient problems
- Foreign Body In Patient9
- No Code Available4
- Insufficient Information2
- Injury1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE TROCARS BROKE DURING INSERTION INTO THE PEDICLE. THERE WAS A TWENTY (20) MINUTES SURGICAL DELAY. THE FRAGMENTS COULD NOT BE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE PATIENT CONSEQUENCES.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 22235892 ↗MalfunctionJun 17, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE TROCARS BROKE DURING INSERTION INTO THE PEDICLE. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. THE FRAGMENT REMAINED IN THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: Foreign Body In Patient
MAUDE report 22235747 ↗MalfunctionJun 17, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE TROCARS BROKE DURING INSERTION INTO THE PEDICLE. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. THE FRAGMENT REMAINED IN THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: Foreign Body In Patient
MAUDE report 22235671 ↗MalfunctionMay 19, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE INSTRUMENT BROKE IN TWO PIECES INTRAOPERATIVELY. APPROXIMATELY TWO (2) 30MM FRAGMENTS REMAINED INSIDE THE PATIENTS L3 PEDICLES. THERE WAS A ONE (1) HOUR SURGICAL DELAY. PATIENT WILL NOT BE SUITABLE FOR AN MRI DUE TO THE STUCK METAL.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 22045691 ↗MalfunctionMay 19, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE INSTRUMENT BROKE IN TWO PIECES INTRAOPERATIVELY. APPROXIMATELY TWO (2) 30MM FRAGMENTS REMAINED INSIDE THE PATIENTS L3 PEDICLES. THERE WAS A ONE (1) HOUR SURGICAL DELAY. PATIENT WILL NOT BE SUITABLE FOR AN MRI DUE TO THE STUCK METAL.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 22045689 ↗MalfunctionApr 23, 2025Break; Entrapment of Device; Material Deformation; Break; Entrapment of Device; Material Deformation
IT WAS REPORTED THAT DURING SURGERY, THE NEEDLES BENT DURING INSERTION. WHEN REMOVING THE CURVED NEEDLES, THE TIPS BROKE OFF. THE TIPS COULD NOT BE REMOVED FROM THE PATIENT AND REMAINED IN THE PATIENT. THERE WAS A SURGICAL DELAY OF TEN MINUTES RELATED TO THE EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 21890155 ↗MalfunctionApr 23, 2025Break; Entrapment of Device; Material Deformation; Break; Entrapment of Device; Material Deformation
IT WAS REPORTED THAT DURING SURGERY, THE NEEDLES BENT DURING INSERTION. WHEN REMOVING THE CURVED NEEDLES, THE TIPS BROKE OFF. THE TIPS COULD NOT BE REMOVED FROM THE PATIENT AND REMAINED IN THE PATIENT. THERE WAS A SURGICAL DELAY OF TEN MINUTES RELATED TO THE EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 21890139 ↗InjuryAug 22, 2024Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT ON (B)(6) 2024, DURING A SURGERY A TROCAR WAS USED TO INSERT CEMENT. AFTER AUGMENTATION THE SURGEON TRIED TO REMOVE THE TROCAR AND IT BROKE. APPROXIMATELY 4CM OF TROCAR REMAIN IN THE VERTEBRAL BODY WITH CEMENT INSIDE. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. THIS REPORT INVOLVES ONE (1) CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 11G X 4 INCHES. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 20035259 ↗InjuryDec 2, 2022Break; Entrapment of Device; Break; Entrapment of Device
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A SPINAL PROCEDURE, THE NEEDLE BROKE WITHIN THE PATIENT¿S PEDICLE. THE BROKEN PIECE REMAINED WITHIN THE PATIENT. NO FURTHER INFORMATION IS KNOWN. THIS REPORT INVOLVES ONE CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 11G X 4 INCHES. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 15906934 ↗MalfunctionOct 7, 2020Break; Break
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT DURING A PROCEDURE WITH VIPER 3D, A TROCAR BROKE IN THE PATIENT'S VERTEBRA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FOUR (4) MINUTE DELAY. THIS REPORT IS FOR ONE (1) CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 11G X 4 INCHES. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10644896 ↗InjuryAug 13, 2019Break; Break
RUPTURE OF THE NEEDLE AS IT HAS BEEN REPORTED IN THE ATTACHED OPERATING REPORT. (SEE ADDITIONAL INFORMATION FOR TRANSLATION). THE LOT OF THE DAMAGED NEEDLE IS NOT KNOW WITH CERTAINLY BECAUSE DURING SURGICAL PROCEDURE HAS BEEN USED TWO DIFFERENT LOTS: 1 PIECE OF LOT 205607 DEADLINE: 07/31/2023. 4 PIECES OF LOT 228932 DEADLINE: 12/31/2023. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.
Patient problems: No Code Available
MAUDE report 8889444 ↗InjuryAug 13, 2019Break; Break
RUPTURE OF THE NEEDLE AS IT HAS BEEN REPORTED IN THE ATTACHED OPERATING REPORT. (SEE ADDITIONAL INFORMATION FOR TRANSLATION). THE LOT OF THE DAMAGED NEEDLE IS NOT KNOW WITH CERTAINLY BECAUSE DURING SURGICAL PROCEDURE HAS BEEN USED TWO DIFFERENT LOTS: 1 PIECE OF LOT 205607 DEADLINE:31-07-2023 4 PIECES OF LOT 228932 DEADLINE:31-12-2023. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.
Patient problems: No Code Available
MAUDE report 8889223 ↗InjuryAug 13, 2019Break; Break
RUPTURE OF THE NEEDLE AS IT HAS BEEN REPORTED IN THE ATTACHED OPERATING REPORT. (SEE ADDITIONAL INFORMATION FOR TRANSLATION). THE LOT OF THE DAMAGED NEEDLE IS NOT KNOW WITH CERTAINLY BECAUSE DURING SURGICAL PROCEDURE HAS BEEN USED TWO DIFFERENT LOTS: 1 PIECE OF LOT 205607 DEADLINE:31-07-2023. 4 PIECES OF LOT 228932 DEADLINE:31-12-2023. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.
Patient problems: No Code Available
MAUDE report 8889175 ↗InjuryAug 13, 2019Break; Break
RUPTURE OF THE NEEDLE AS IT HAS BEEN REPORTED IN THE ATTACHED OPERATING REPORT. (SEE ADDITIONAL INFORMATION FOR TRANSLATION) THE LOT OF THE DAMAGED NEEDLE IS NOT KNOW WITH CERTAINLY BECAUSE DURING SURGICAL PROCEDURE HAS BEEN USED TWO DIFFERENT LOTS: 1 PIECE OF LOT 205607 DEADLINE:07/31/2023, 4 PIECES OF LOT 228932 DEADLINE:12/31/2023. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.
Patient problems: No Code Available
MAUDE report 8889124 ↗InjuryFeb 12, 2018Break; Material Fragmentation; Break; Material Fragmentation
JAMSHIDI NEEDLE CANNULATED SLEEVE BROKEN AND REMAINED IN PATIENT L2 RIGHT SIDE PEDICLE. PATIENT DIAGNOSE AS L2 PSEUDARTHROSIS; BONE QUALITY IS EXTREMELY DENSE. DOCTOR TRIED TO CREATE TRAJECTORY FOR PACKING BONEGRAFT VIA L2 PEDICLE TO L2 VERTEBRAL BODY BY USING OUR JAMSHIDI NEEDLE. HOWEVER, DUE TO BONE QUALITY, THE NEEDLE WAS UNABLE TO PULL OUT AFTER ENTERING PATIENT'S L2 PEDICLE. AFTER SEVERAL TRAIL, DOCTORS MANAGED TO PULL OUT THE INNER NEEDLE AND MOST PARTS OF THE CANNULATED SLEEVE, AND REMAIN ~2 CM BROKEN CANNULATED SLEEVE IN-SITU. PATIENT CONSEQUENCE? :UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.
Patient problems: Injury
MAUDE report 7264707 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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