NA 04.615.124Recalls & reported problems
Synthes GmbH · 4.0MM TI CANCELLOUS POLYAXIAL SCREW 24MM FOR 4.0MM RODS · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034740003), received between Apr 16, 2018 and Aug 14, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 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
Device problems
- Break2
Patient problems
- Injury1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2020Break; Break
IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION ON (B)(6) 2020, THE SCREW HEAD/ SCREW SHANK OF THE 4.0MM CANCELLOUS POLYAXIAL SCREW BROKE OFF THE TOP OF THE SCREW. THE ISSUE HAPPENED WHILE THE SURGEON WAS BACKING OUT THE SCREW IN AN ATTEMPT TO BRING THE SCREW HEAD CLOSER TO THE ROD. A FRAGMENT WAS GENERATED AND WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES: SCREWDRIVER (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), ROD (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A 4.0MM TITANIUM (TI) CANCELLOUS POLYAXIAL SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Injury
MAUDE report 10408949 ↗MalfunctionApr 16, 2018Break; Break
IT WAS REPORTED THAT DURING A POSTERIOR CERVICAL FUSION PROCEDURE ON (B)(6) 2018, AFTER THE PLACEMENT OF THE SCREWS AND AS SURGEON WAS TRYING TO REDUCE THE ROD TO THE SCREW USING THE PISTOL-GRIP PERSUADER, MOVING ON TO THE RODDING STEP, THE HEAD OFF A POLYAXIAL SCREW FROM POPPED OFF A SYNAPSE OCCIPITO- CERVICAL FUSION SYSTEM (OCT) SET. THE SCREW WAS REMOVED AND REPLACED. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: PISTOL-GRIP PERSUADER (PART #, LOT # QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7434583 ↗
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- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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