UNIVERSAL NEURO 2, QUIKFLAP 50-15904Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · NEURO SCREWS,CROSS-PIN,SELF-DRILLING · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 37613154481775), received between Sep 21, 2018 and Sep 21, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Slipped” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Slipped2
Patient problems
- Injury1
- Laceration(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2018Device Slipped
IT WAS REPORTED THAT DURING BRAIN TUMOR OPERATION, THE SCREW SLIPPED AND HIT THE DURA MATER OF THE BRAIN. THE DURA MATER WAS REPAIRED, THE OPERATION WAS DELAYED FOR AN HOUR.
Patient problems: Laceration(s)
MAUDE report 7898048 ↗InjurySep 21, 2018Device Slipped
IT WAS REPORTED THAT DURING THE BRAIN TUMOR OPERATION, THE SCREW SLIPPED AND HIT THE DURA MATER OF THE BRAIN. THE DURA MATER WAS REPAIRED AND THE OPERATION WAS DELAYED FOR AN HOUR.
Patient problems: Injury
MAUDE report 7898046 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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