NA 216.035Recalls & reported problems
Synthes GmbH · 6.5MM CANCELLOUS BONE SCREW 16MM THREAD/35MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10886982155184), received between Nov 2, 2018 and Nov 2, 2018 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
- Material Twisted/Bent1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 2, 2018Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED ON (B)(6) 2018, DURING STERILE PROCESSING, IT WAS FOUND OUT THAT THE TWO (2) HEXAGON SCREW RECESSED OF THE PARTIALLY THREADED HAD A METAL SHAVING THAT WAS BROKE LOOSE AND ONE (1) HEXAGON SCREW HAD A METAL SHAVING THAT WAS STILL STUCK IN THE HEXAGON SCREW. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 6.5MM CANCELLOUS BONE SCREW 16MM THREAD/35MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8034084 ↗
Other Screw, fixation, bone devices
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- 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 STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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