NA 04.615.126Recalls & reported problems
Synthes GmbH · 4.0MM TI CANCELLOUS POLYAXIAL SCREW 26MM FOR 4.0MM RODS · Class 2 · Implant
Data updated Oct 13, 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 10705034740010), received between Mar 30, 2020 and Sep 22, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Compatibility Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2022Compatibility Problem; Compatibility Problem
DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING O-T FUSION (CERVICAL SPINE) FOR CERVICAL MYELOPATHY, THE SCREW IN QUESTION COULD NOT BE ATTACHED TO THE TWO SCREWDRIVERS IN QUESTION. THE OPERATION WAS COMPLETED SUCCESSFULLY USING ANOTHER SYNAPSE SCREWDRIVER. THERE WAS A DELAY OF APPROXIMATELY 30 MINUTES. THIS REPORT IS FOR A 4.0MM TI CANCELLOUS POLYAXIAL SCREW 26MM FOR 4.0MM RODS. THIS IS REPORT 1 OF 7 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15463446 ↗InjuryMar 30, 2020Break; Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING THE POSTOPERATIVE VISIT , THERE WAS A BROKEN TITANIUM CANCELLOUS POLYAXIAL SCREW FOUND AT THE THORACIC 1 LEVEL POST POSTERIOR CERVICAL FUSION PROCEDURE. THE PATIENT HAD SURGERY SIX MONTHS AGO. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES REPORTED: UNK - LAMINA/PEDICLE/PROCESS HOOKS: SYNAPSE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNK - MONO/POLYAXIAL SCREW COLLARS/SLEEVES/HEADS: SYNAPSE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNK - MONO/POLYAXIAL SCREWS: SYNAPSE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNK - RODS: SYNAPSE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES 1 DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 9901184 ↗
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 79-2003Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604024Medtronic 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 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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