NA 04.615.024Recalls & reported problems
Synthes GmbH · 3.5MM 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034739786), received between Oct 22, 2019 and Oct 22, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE REPLACING THE ROD, SURGEON WAS ATTEMPTING THE USE THE REDUCER IN ACCORDANCE WITH THE SURGICAL TECHNIQUE. THE ROD WAS APPROXIMATE 5MM PROUD OF THE TULIP HEAD AT C5 AND C6. UPON REDUCING THE ROD, THE TULIP HEAD DISENGAGED FROM THE SCREW SHANK AT C5. DR. (B)(6) THEN MOVED ON TO C6 WHERE THE SAME EVENT OCCURRED. PATIENT OUTCOME AND STATUS IS UNKNOWN. THIS COMPLAINT IS LINKED TO (B)(4). CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (QUANTITY: 1). THIS COMPLAINT INVOLVES ONE (1) 3.5MM TI CANCELLOUS POLYAXIAL SCREW 24MM FOR 4.0MM ROD-STER. THIS IS 2 OF 2 FOR REPORT (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9219851 ↗
Other Orthosis, cervical pedicle screw spinal fixation devices
- INFINITY™ Occipitocervical Upper Thoracic System 3604026Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation2 recalls1 report
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- INFINITY™ Occipitocervical Upper Thoracic System 360PT4022Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- CONNECTOR 79-2002Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604532Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604024Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- OASYS 48551000Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation45 reports
- YUKON OCT Spinal System 7601-05030VB Spine LLC · Orthosis, cervical pedicle screw spinal fixation15 reports
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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