NA 212.216Recalls & reported problems
Synthes GmbH · 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 44MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982152237), received between Nov 10, 2021 and Jul 11, 2023 — classified as 2 injuries.
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 Problem2
Patient problems
- Bone Fracture(s)1
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2023, WHERE SYNTHESE STAINLESS STEEL CANNULATED BONE SCREWS WERE USED. DURING THE PROCEDURE A NUMBER OF SYNTHESE TRAUMA PRODUCTS WERE IMPLANTED, INCLUDING A HIP PLATE, CORTEX SCREWS AND SIDE SCREWS. POST-SURGERY, THE PATIENT HAS BEEN EXPERIENCING SYMPTOMS THAT LEAD THEM TO BELIEVE THEY MAY BE HAVING AN ALLERGIC REACTION TO THE IMPLANTED ITEMS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 44MM. THIS IS REPORT 5 OF 7 FOR (B)(4).
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 17299998 ↗InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2021. THE PATIENT UNDERWENT FOR A SURGERY. DURING A SURGERY, THERE WAS A REVISION FIXATION DUE TO FRACTURE DISTAL TO HARDWARE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 44. THIS IS REPORT 6 OF 6 FOR (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 12788705 ↗
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- 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 STP3.5-400Nuvasive 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.
How reports and recalls are matched · Editorial policy · Report an error on this page