NA 50-20410Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · Bone Screws, Cross-Pin · Class 2 · Implant
Data updated Oct 18, 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 37613154184164), received between Jun 15, 2020 and Mar 18, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Appears to Trigger Rejection1
Patient problems
- Unspecified Infection2
- Abscess1
- Pain1
- Post Operative Wound Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT DEVELOPED OSTEOMYELITIS WITH A NON UNION FRACTURE AND A SCREW WAS BROKEN.
Patient problems: Unspecified Infection
MAUDE report 24626613 ↗InjuryJun 15, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED THAT THE PATIENT PRESENTED POST-OPERATION WITH SIGNS OF INFECTION (PAIN, ABSCESS) ON RIGHT PARASYMPHYSIS AREA. THE SURGEON REMOVED THE HARDWARE AND DID NOT RE-PLATE AS THE PATIENT'S MANDIBLE FRACTURE LOOKED HEALED. PATIENT CAME BACK AGAIN WITH PAIN, AND THE SURGEON NOTED TORSIONAL MOVEMENT IN THE MANDIBLE, SO IT WAS RE-PLATED. THERE WAS NO SIGN OF INFECTION DURING THE REVISION SURGERY.
Patient problems: Abscess; Pain; Post Operative Wound Infection; Unspecified Infection
MAUDE report 10155498 ↗
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 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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