NA 04.211.052Recalls & reported problems
Synthes GmbH · 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 52MM · 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 10886982119186), received between Jun 12, 2024 and Jun 12, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Entrapment of Device1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2024Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A REVISION SURGERY, WHICH HAS BEEN REPORTED IN (B)(4) (TR202300130). AFTER THE REVISION SURGERY, A REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2024, AS BONE FUSION WAS ACHIEVED. IN THE REMOVAL SURGERY, THE SCREW IN QUESTION BROKE OFF. THE SURGEON TRIED TO REMOVE IT BUT GAVE UP REMOVING IT BECAUSE IT WAS DIFFICULT TO REMOVE AND DETERMINED TO LEAVE IT IN THE PATIENT¿S BODY. SINCE (2) SCREWS HAD BEEN UNABLE TO BE REMOVED AND LEFT IN THE BODY IN THE PREVIOUS REVISION SURGERY, A TOTAL OF (3 )SCREWS HAVE BEEN LEFT IN THE BODY, INCLUDING THE 1ST SCREW THAT COULD NOT BE REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR ONE (1) 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 52MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 19524042 ↗
Other Screw, fixation, bone devices
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- 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 13, 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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