NA 02.127.158TSRecalls & reported problems
Synthes GmbH · 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/58MM · 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 10886982307217), received between Nov 10, 2020 and Nov 10, 2020 — 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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- 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.
InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2020, NONUNION OCCURRED AND 6-HOLE VA-LCP MEDIAL DISTAL PLATE WITH SIX 2.7MM VA LOCKING SCREWS, THREE 3.5 CORTICAL SCREWS, AND ONE 3.5 LOCKING SCREW WERE ALL REMOVED. THE SCREW HEAD MAY HAVE ALREADY BEEN BROKE PRIOR TO THE REMOVAL CASE. THERE WAS NO SURGICAL DELAY REPORTED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWELVE (12) DEVICES. THIS REPORT IS FOR (1) 3.5MM VARIABLE ANGLE LOCKING: SCREW/SLF-TPNG/STOREDRV/58MM. THIS IS REPORT 3 OF 10 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 10818351 ↗
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- 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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