NA 02.130.314Recalls & reported problems
Synthes GmbH · 2.0MM VA-LCKNG SCREW SLF-TPNG WITH T6 STARDRIVE RECESS 14MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982045218), received between Nov 5, 2018 and Mar 23, 2023 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (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 18, 2026.
Most reported problems
Device problems
- Mechanical Problem2
- Device-Device Incompatibility1
- Material Twisted/Bent1
Patient problems
- No Code Available2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
THE REPORTED ISSUE WAS DISCOVERED DURING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16602606 ↗InjuryNov 5, 2018Mechanical Problem; Mechanical Problem
IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RADIAL NECK/HEAD UTILIZING THE VARIABLE ANGLE (VA) LOCKING Y-PLATE ON (B)(6) 2018. IT WAS FURTHER REPORTED THE FIXATION DID NOT HOLD. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED THE Y-PLATE, FOUR (4) VA LOCKING SCREWS AND FOUR (4) CORTEX SCREWS. THIS REPORT IS FOR ONE (1) 2.0MM VA LOCKING SCREW. THIS IS REPORT 6 OF 9 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 8037312 ↗InjuryNov 5, 2018Mechanical Problem; Mechanical Problem
IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RADIAL NECK/HEAD UTILIZING THE VARIABLE ANGLE (VA) LOCKING Y-PLATE ON (B)(6) 2018. IT WAS FURTHER REPORTED THE FIXATION DID NOT HOLD. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED THE Y-PLATE, FOUR (4) VA LOCKING SCREWS AND FOUR (4) CORTEX SCREWS. THIS REPORT IS FOR ONE (1) 2.0MM VA LOCKING SCREW. THIS IS REPORT 1 OF 9 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 8037293 ↗
Other Screw, fixation, bone devices
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- 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.
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