NA 6000-010-000Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · POINT CALIBRATION DEVICE (PCD) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540245090), received between May 20, 2019 and Apr 28, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Intermittent Communication Failure1
Patient problems
- No Patient Involvement2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2021Intermittent Communication Failure; Intermittent Communication Failure
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DEVICE WAS INACCURATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11738763 ↗MalfunctionJul 12, 2019Break; Break
DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE BATTERY COMPARTMENT BROKE OFF POSING THE RISK OF A SMALL COMPONENT BEING LOST IN THE SURGICAL SITE. . NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Patient problems: No Patient Involvement
MAUDE report 8786730 ↗MalfunctionMay 20, 2019Break; Break
THE CUSTOMER REPORTED THAT PRIOR TO A CASE, IT WAS OBSERVED THAT THE COMPARTMENT THAT HOLDS THE BATTERY IS BROKEN OR CRACKED; THIS POSES THE RISK OF A SMALL COMPONENT BEING LOST IN THE SURGICAL SITE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED PRIOR TO A PROCEDURE AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Patient problems: No Patient Involvement
MAUDE report 8623561 ↗
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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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