NA 50-20406Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · Bone Screws, Cross-Pin · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 37613154184133), received between Sep 13, 2023 and May 19, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (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
- Loss of Osseointegration1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE PATIENT RETURNED TO THE HOSPITAL WITH A BROKEN IMPLANTED PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22043477 ↗InjurySep 13, 2023Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT IT WAS FOUND THAT THE SCREWS WERE LOOSE. THE SURGEON PERFORMED A REVISION SURGERY AND ELECTED TO REMOVE A PORTION OF THE PLATE AND SCREWS BY CUTTING IT WITH A FISSURE BURR. SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17740757 ↗
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- 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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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