NA 209.680Recalls & reported problems
Synthes GmbH · 7.3MM CANNULATED SCREW FULLY THREADED/80MM · Class 2 · Implant
Data updated Oct 16, 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 10886982150837), received between Dec 7, 2017 and Dec 7, 2017 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION ON (B)(6) 2017, DUE TO PAIN. THE DEVICE WAS NOT BROKEN AND WAS REMOVED INTACT. THE PATIENT WAS INITIALLY IMPLANTED WITH A 7.3MM CANNULATED SCREW FULLY THREADED/80MM IN THE LEFT SACROILIAC (SI) JOINT ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A SIMILAR ITEM. REVISION WAS COMPLETED SUCCESSFUL WITH THE PATIENT IN A STABLE CONDITION. THIS REPORT IS FOR ONE (1) 7.3MM CANNULATED SCREW FULLY THREADED/80MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Code Available; Pain
MAUDE report 7097670 ↗
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- 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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