NA 6002-050-000Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · ROTATIONAL NAVIGATION ADAPTER · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540245984), received between Mar 27, 2019 and Jun 18, 2024 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Imprecision” (5 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.
Reports received per month
Most reported problems
Device problems
- Imprecision5
- Incorrect Measurement5
- Deformation Due to Compressive Stress1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2024Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement
IT WAS REPORTED THAT DURING A CASE, THE ROTATIONAL ADAPTER WAS INACCURATE EVEN AFTER RECALIBRATING THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19560128 ↗MalfunctionMay 9, 2024Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement
IT WAS REPORTED THAT THE ACCURACY OF THE ROTATIONAL ADAPTER WAS OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19282734 ↗MalfunctionMay 9, 2024Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement
IT WAS REPORTED THAT THE ACCURACY OF THE ROTATIONAL ADAPTERS WAS OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19282733 ↗MalfunctionMay 9, 2024Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement
IT WAS REPORTED THAT DURING A CASE THE ROTATIONAL ADAPTOR WAS INACCURATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19282732 ↗MalfunctionMay 9, 2024Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement
IT WAS REPORTED THAT DURING A CASE THE ROTATIONAL ADAPTOR WAS INACCURATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19282731 ↗MalfunctionAug 21, 2023Fracture; Fracture
PER THE CUSTOMER THE DEVICE WILL BREAK IF USED WITH A 10CM SERRATO SCREW. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.
Patient problems: Insufficient Information
MAUDE report 17585630 ↗MalfunctionMar 27, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE PRODUCT WAS FOUND TO BE BENT ON THE HANDLE INTERFACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8457077 ↗
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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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