NA 04.112.625SRecalls & reported problems
Synthes GmbH · 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS3/ RIGHT/ STERILE · 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 10886982279316), received between Jul 3, 2023 and Jul 3, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (1 report).
1 other recall cover devices cleared under the same FDA submission (K201321, K203414); they may or may not involve this specific model.
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
- Migration1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2023Migration; Migration
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ORIF SURGERY FOR CLAVICLE MIDSHAFT FRACTURE WITH IMPLANTS IN QUESTION AND 2 SUTURES. AFTER SURGERY, ON (B)(6) 2023, IT WAS FOUND THAT THE LATERAL SIDE OF THE PLATE APPEARED TO BE SLIGHTLY RAISED. ON (B)(6) 2023, IT WAS CONFIRMED THAT THE 1 SCREW INSERTED INTO THE LATERAL BONE FRAGMENT WAS BROKEN. ON (B)(6) 2023, IT WAS CONFIRMED THAT A TOTAL OF 4 SCREWS INSERTED INTO THE LATERAL BONE FRAGMENT WERE BROKEN. IT IS UNKNOWN WHICH SCREWS ARE INSERTED INTO WHICH SCREW HOLES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS3/ RIGHT/ STERILE. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 17246202 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K201321, K203414. One submission often covers many models, so check the product and lot details in each record.
- Z-1241-2024 · Jan 24, 2024 · Open, ClassifiedVA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S
Other Plate, fixation, bone devices
- Lapiplasty System 2 SK14Treace Medical Concepts, Inc. · Plate, Fixation, Bone260 reports
- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive Specialized Orthopedics, Inc. · Plate, 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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