UNIVERSAL NEURO 3 53-34216Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · Straight Plate, 16mm Bar · Class 2 · Implant
Data updated Oct 16, 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 04546540684677), received between Mar 14, 2023 and Mar 14, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Failure of Implant1
- Inadequate Osseointegration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT HAD POST OPERATIVE IRRITATION. SURGEON REVIEWED A POST OP SCAN WHICH SHOWED THE PLATE AND SCREW WERE LOOSE, WHICH COULD RESULT IN DAMAGE OF BONE, TISSUE OR STRUCTURES, REQUIRING SURGERY TO PREVENT PERMANENT IMPAIRMENT. THERE WAS A REVISION SURGERY AND DEVICES WERE REMOVED AND FIXATED. HE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 16537276 ↗
Other Plate, cranioplasty, preformed, alterable devices
- OsteoMed 218-1604Osteomed LLC · Plate, cranioplasty, preformed, alterable1 recall6 reports
- OsteoMed 218-1604-SP-10Osteomed LLC · Plate, cranioplasty, preformed, alterable1 recall0 reports
- NA 56-90614Stryker Leibinger GmbH & Co. KG · Plate, cranioplasty, preformed, alterable1 recall0 reports
- NA 78-50030Stryker Leibinger GmbH & Co. KG · Plate, cranioplasty, preformed, alterable21 reports
- THINFLAP SYSTEM 91-6704Biomet Microfixation, Inc · Plate, cranioplasty, preformed, alterable19 reports
- NA 78-50040Stryker Leibinger GmbH & Co. KG · Plate, cranioplasty, preformed, alterable18 reports
- NA 78-10030Stryker Leibinger GmbH & Co. KG · Plate, cranioplasty, preformed, alterable13 reports
- NA 78-40040Stryker Leibinger GmbH & Co. KG · Plate, cranioplasty, preformed, alterable11 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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