NA 12-01542SRecalls & reported problems
Stryker Leibinger GmbH & Co. KG · 2 HOLE PLATES W/TAB(3) SD SCREW(6) AXS · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327282344), received between Jun 17, 2024 and Jun 17, 2024 — classified as 1 injury.
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
- Device Appears to Trigger Rejection1
- Patient-Device Incompatibility1
Patient problems
- Foreign Body Reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2024Device Appears to Trigger Rejection; Patient-Device Incompatibility; Device Appears to Trigger Rejection; Patient-Device Incompatibility
IT WAS REPORTED THE SURGEON WILL PERFORM A REVISION SURGERY TO REMOVE THE DEVICES DUE TO PATIENT EXPERIENCING AN ALLERGIC REACTION.
Patient problems: Foreign Body Reaction
MAUDE report 19554370 ↗
Other FASTENER, PLATE, CRANIOPLASTY devices
- RapidSorb 530.553.01SSynthes GmbH · FASTENER, PLATE, CRANIOPLASTY1 recall0 reports
- "1.5MM" SYSTEM 95-6104Biomet Microfixation, Inc · FASTENER, PLATE, CRANIOPLASTY30 reports
- "1.5MM" SYSTEM 95-6105Biomet Microfixation, Inc · FASTENER, PLATE, CRANIOPLASTY16 reports
- UNIVERSAL NEURO 3 56-15904Stryker Leibinger GmbH & Co. KG · FASTENER, PLATE, CRANIOPLASTY7 reports
- 1.5MM SYSTEM 91-6104-50Biomet Microfixation, Inc · FASTENER, PLATE, CRANIOPLASTY6 reports
- 1.5MM SYSTEM 91-6105XBiomet Microfixation, Inc · FASTENER, PLATE, CRANIOPLASTY5 reports
- Universal Neuro 3 56-15934Stryker Leibinger GmbH & Co. KG · FASTENER, PLATE, CRANIOPLASTY4 reports
- Universal Neuro 3 56-15034Stryker Leibinger GmbH & Co. KG · FASTENER, PLATE, CRANIOPLASTY2 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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