VOLT 02.527.117Recalls & reported problems
Synthes GmbH · 2.7MM VOLT(TM) CORTEX SCREW 17MM T8 · Class 2 · Implant
- 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 10886982322302), received between Sep 11, 2025 and Sep 11, 2025 — classified as 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Entrapment of Device1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT POSTOPERATIVELY, WHILE REMOVING A 2.7MM VOLT CORTEX SCREW FROM THE PATIENT'S RADIUS, THE HEAD OF THE SCREW WAS SHEARED OFF. IN THE SAME CASE, THE HEAD OF ANOTHER 2.7MM VOLT CORTEX SCREW WAS SHEARED OFF UPON INSERTION AND TIGHTENING. THERE WAS A SURGICAL DELAY OF 10 MINUTES. THE BROKEN SCREW SHAFTS REMAINED IN PATIENT'S RADIUS.
Patient problems: Foreign Body In Patient
MAUDE report 23025332 ↗
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- PRECICE® Bone Transport System STP3.5-375Nuvasive 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 STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.