NA 212.202Recalls & reported problems
Synthes GmbH · 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 16MM · 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 10886982152091), received between Sep 20, 2021 and Sep 20, 2021 — 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
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A REMOVAL PROCEDURE, THE PLATE WAS REMOVED DUE TO BONE HEALING FAILURE. THIS WAS IMPLANTED NO (B)(6) 2021. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 16MM. THIS REPORT IS 3 OF 10 FOR (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 12502124 ↗
Other APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices
- PRECICE® Plating System LP4.5-DLF31Nuvasive Specialized Orthopedics, Inc. · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component3 recalls0 reports
- R3 71364451Smith & Nephew, Inc. · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT145 reports
- DFS HA BONE SCREWS HAA60-11030Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAA60-15040Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAB60-12040Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAA60-18040Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAA60-15060Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAA60-15020Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 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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