NA 02.206.230Recalls & reported problems
Synthes GmbH · 3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/STAR DRIVE/30MM · 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 10886982051080), received between Jul 15, 2019 and Jul 15, 2019 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Impaired Healing1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 15, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY OF A VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) ANTEROLATERAL DISTAL TIBIAL PLATE 10 HOLES RIGHT DUE TO NONUNION. THERE WERE SIX (6) 2.7MM VARIABLE ANGLE LOCKING SCREWS REMOVED, OUT OF SIX (6) SCREWS TWO (2) WERE BROKEN. ALSO HAD FOUR (4) 3.5 CORTEX SCREWS THAT WERE REMOVED AS WELL, THREE (3) OUT OF 4 SCREWS WERE BROKEN. THE 2.7MM LOCKING COMPRESSION PLATE 7 HOLES PLATE WAS REMOVED, WITH THAT PLATE THERE WERE (6) 2.7MM CORTEX SCREWS ONE (1) WAS BROKEN. THE SURGEON REPLACE THE TIBIAL WITH ANOTHER VARIABLE ANGLE (VA) ANTEROLATERAL DISTAL TIBIA PLATE. IT WAS A 14-HOLE RIGHT. ENDED UP WITH A (4) CORTEX SCREWS IN THE SHAFT AND 5 (VA) LOCKING SCREW DISTALLY. THERE WAS ONE FRAGMENT THAT IS NON-RETRIEVABLE IT WAS THE SCREWS WERE INCASED IN BONE, IT WAS NOT REMOVED TO AVOID EXTENSIVE DISSECTION. IT WAS LEFT IN THE PATIENT AND NO PLAN TO REMOVE. THE ORIGINAL DATE OF IMPLANT WAS ON (B)(6) 2018. OTHER THAN THE TIMES IT TAKES TO REMOVE THE HARDWARE THERE WERE NO OTHER SURGICAL DELAYS. ALL OTHER HARDWARE WAS REMOVED COMPLETELY AND SUCCESSFULLY. PROCEDURE OUTCOME WAS GOOD. PATIENT WAS IN STABLE CONDITION AND TOLER
Patient problems: Impaired Healing; No Code Available
MAUDE report 8789551 ↗
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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.
How reports and recalls are matched · Editorial policy · Report an error on this page