SMARTLOCK 55-10554Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · LOCKING PLATE,SAGITTAL SPLIT,6MM BAR · Class 2 · Implant
Quick summary
This Stryker SmartLock locking bone plate is used to hold bone fragments together, including in sagittal split procedures. The 30 reports mostly describe new fractures, infection around the implanted plate, and the body rejecting the implant; one report describes the plate breaking when it was removed. There are 26 injuries and no deaths. No recalls name this device, and reports have risen from 6 to 17 in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 04546540366245), received between Jun 15, 2018 and Sep 16, 2026 — classified as 26 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (13 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem14
- Device Appears to Trigger Rejection13
- Fracture11
- Contamination3
- Material Deformation1
Patient problems
- Unspecified Infection18
- No Clinical Signs, Symptoms or Conditions11
- Fistula3
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Device Appears to Trigger Rejection
It was reported that an infection has occurred.
Patient problems: Insufficient Information
MAUDE report 50785779 ↗InjuryMay 28, 2026Fracture
IT WAS REPORTED THAT THE PLATE WAS FRACTURED AND REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25313381 ↗InjuryApr 30, 2026Fracture
IT WAS REPORTED THAT THE IMPLANTED PLATE WAS BROKEN AND A REVISION SURGERY IS NECESSARY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25043174 ↗InjuryApr 29, 2026Device Appears to Trigger Rejection
IT WAS REPORTED THAT THERE WAS AN INFECTION WHEN THE PLATE WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 25027043 ↗InjuryApr 13, 2026Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DISCHARGE WAS OBSERVED ON BOTH SIDES OF THE LOWER JAW DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24857519 ↗InjuryApr 9, 2026Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION IN THE IMPLANTED PLATES.
Patient problems: Unspecified Infection
MAUDE report 24829618 ↗InjuryApr 2, 2026Fracture
No new information.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767823 ↗InjuryMar 5, 2026Fracture
No new information.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24523649 ↗InjuryFeb 6, 2026Fracture
No new information.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24278020 ↗InjuryDec 18, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
InjuryDec 18, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
InjuryDec 18, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
InjuryDec 18, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
MalfunctionDec 17, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827584 ↗MalfunctionDec 17, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827583 ↗MalfunctionDec 17, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827576 ↗MalfunctionDec 17, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827570 ↗InjuryOct 27, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
InjuryOct 27, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
InjuryOct 27, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
InjuryOct 27, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
InjuryOct 27, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
InjuryJun 17, 2025Fracture; Material Deformation; Fracture; Material Deformation
IT WAS REPORTED THAT THE PLATE WAS DAMAGED POSTOPERATIVELY AND NEEDS TO BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22230205 ↗InjurySep 28, 2021Fracture; Fracture
IT HAS BEEN REPORTED THAT THE PATIENT HAD EXPERIENCED A PLATE BREAKAGE POSTOPERATIVELY. DUE TO THE PLATE BREAKAGE, A REVISION SURGERY WILL BE PERFORMED TO EXPLANT THE PLATE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12540777 ↗InjuryJun 28, 2018Contamination
IT HAS BEEN REPORTED BY THE CUSTOMER THAT THE PATIENT HAD AN INFECTION POSTOPERATIVELY. POTENTIALY, DUE THE INFECTION THE SURGEON MAY HAVE TO EXPLANT THE PLATE AND SCREWS.
Patient problems: Unspecified Infection
MAUDE report 7647875 ↗
Other PLATE, BONE devices
- MatrixNEURO 04.503.104.01Synthes GmbH · PLATE, BONE252 reports
- RapidSorb 806.004.02SSynthes GmbH · PLATE, BONE146 reports
- TruMatch SD980.001Materialise NV · Plate, Bone1 recall21 reports
- Matrix 04.511.225.01Synthes GmbH · PLATE, BONE62 reports
- NA 400.834Synthes GmbH · PLATE, BONE58 reports
- TruMatch SD980.016Materialise NV · Plate, Bone55 reports
- ProPlan CMF SD900.101Materialise NV · Plate, Bone1 recall1 report
- TruMatch SD980.013Materialise NV · Plate, Bone1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.