NA 04.615.130Recalls & reported problems
Synthes GmbH · 4.0MM TI CANCELLOUS POLYAXIAL SCREW 30MM FOR 4.0MM RODS · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034740034), received between Oct 12, 2020 and Oct 12, 2020 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN AP CERVICAL FUSION PROCEDURE, THE LATERAL MASS SCREWS WERE PLACED AND THE FIRST 2.4MM HOLE WAS DRILLED TO 20MM DEPTH IN THE LEFT C2 PARS/PEDICLE. A FLUORO IMAGE WAS TAKEN WHICH SHOWED THE SCREW TO BE DISTINCTLY BENT AND DIVERTED FROM THE PREPARED HOLE. IT APPEARED THE SCREW HAD DEFLECTED CRANIAL AND MEDIAL FROM THE PREPARED HOLE AND WAS PARTIALLY IN THE SPINAL CANAL. THE SURGERY WAS PAUSED TO TAKE A SECOND INTRAOPERATIVE CT SCAN TO VERIFY THE LOCATION OF THE SCREW. THE SURGEON THEN DECIDED TO REMOVE THE SCREW. THE TYPICAL SYNAPSE SCREWDRIVER WAS RE-ENGAGED AND THE BENT SCREW WAS REMOVED. THE HANDLE WAS ¿WOBBLED¿ AS THE SCREW CAME OUT TO ALLOW THE SCREW TO COME OUT AS STRAIGHT AS POSSIBLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SCREW. NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SPACER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). UNKNOWN VECTRA PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). UNKNOWN DRILL GUIDE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). UNKNOWN DRILL BIT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). UNKNOWN SYNAPSE DRIVER (
Patient problems: Injury
MAUDE report 10662254 ↗
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
- 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
- CONNECTOR 79-2003Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 360PT4022Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- OASYS 48551000Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation45 reports
- SYMPHONY 1020-35-112Medos International Sàrl · Posterior cervical screw system6 deaths15 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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