NA 55-07765Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · L-PLATE, 100 DEGREE, 8MM BAR, RIGHT, GSP · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540366146), received between May 23, 2023 and Jun 16, 2023 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (4 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.
Most reported problems
Device problems
- Fracture4
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Nonunion/Delayed-union Bone Fracture2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 16, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PLATE WAS BROKEN AND A REVISION SURGERY WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17144220 ↗MalfunctionJun 15, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PLATES WERE DISCOVERED TO BE BROKEN AND A REVISION SURGERY WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17135954 ↗InjuryMay 23, 2023Fracture; Fracture
IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT UPON RE-OPERATION TO EXPLANT THE PLATES DUE TO THE MAXILLA SHIFTING, IT WAS DISCOVERED THAT THE PLATES WERE FRACTURED.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 16987433 ↗InjuryMay 23, 2023Fracture; Fracture
IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT UPON RE-OPERATION TO EXPLANT THE PLATES DUE TO THE MAXILLA SHIFTING, IT WAS DISCOVERED THAT THE PLATES WERE FRACTURED.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 16987428 ↗
Other PLATE, BONE devices
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- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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