NA 78-30028Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · CUSTOMIZED MAND. RECON PLATE28, HEMI · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252599654), received between Sep 13, 2023 and Jan 28, 2026 — classified as 3 injuries.
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 Problem3
Patient problems
- Unspecified Infection3
- Osteomyelitis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem
InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. THE SURGERY WAS PERFORMED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 17741059 ↗InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THAT A REVISION SURGERY WAS PERFORMED AND COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 17740853 ↗
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 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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