NA 02.127.165Recalls & reported problems
Synthes GmbH · 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/65MM · 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 10886982043351), received between Jul 27, 2021 and Sep 15, 2022 — 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
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2022 ALL IMPLANTS REMOVED WITHOUT INCIDENT. PATIENT WAS INFECTED. CLEAN OUT CANAL THROUGH REAMING AND IRRIGATION. IMPLANT OF AN ANTIBIOTIC COATED NAIL. NO IMPLANTS TO BE RETURNED. THIS REPORT IS FOR ONE (1)3.5 VA LCKNG SCR SLF-TPNG/SD/65. THIS IS REPORT 8 OF 11 FOR COMPLAINT.
Patient problems: Unspecified Infection
MAUDE report 15429938 ↗InjuryJul 27, 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 AN OPENING WEDGE TIBIA OSTEOTOMY PROCEDURE TO CORRECT A VALGUS DEFORMITY ASSOCIATED WITH A PREVIOUS MVA. THE PATIENT HAD AN UNKNOWN PLATE AND SCREWS ON THE POSTERIOR MEDIAL ASPECT OF THE PROXIMAL TIBIA. TO PERFORM THE OSTEOTOMY PROCEDURE, THE SURGEON REMOVED TWO 3.5MM LOCKING SCREWS FROM THE POSTEROMEDIAL PLATE. THE PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT OUTCOME. CONCOMITANT DEVICE REPORTED: UNK - PLATE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 3.5MM VARIABLE ANGLE LOCKING. THIS REPORT IS 1 OF 2 FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12228033 ↗
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- PRECICE® Plating System LP4.5-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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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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