GAMMA 1320-5350Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540520340), received between Oct 30, 2020 and Oct 30, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Align” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2020Failure to Align; Failure to Align

  AS REPORTED: "DURING THE CALIBRATION OF THE DISTAL AIMING DEVICE IN A GAMMA3 OPERATION, IT WAS FOUND INTRAOPERATIVELY THAT THE TOLERANCE DEVIATES IN THE LONGITUDINAL AXIS, BUT THAT THIS CANNOT BE SET VIA THE AIMING DEVICE. THE DEVIATION WAS ESTIMATED TO BE 1MM SO THAT THE DRILL COULD NOT PASS. STRYKER EMPLOYEE CHECKED ALL AIMING BARS IN THE CLINIC IMMEDIATELY AFTER THE EVENT WAS ANNOUNCED. IT WAS FOUND THAT THE DEVIATION CAN ALWAYS BE ENFORCED IN DIFFERENT COMBINATIONS, SINCE THE TOLERANCE OF THE PIN IN THE ADJUSTING DEVICE IN PARTICULAR ALLOWS A SLIGHT ROTATION. IN EXTREME CASES, THIS LEADS TO THE DEVIATION DESCRIBED ABOVE. THE DISTAL LOCKING HAD TO BE DONE MANUALLY ACCORDING TO THE STANDARD METHOD SURGICAL DELAY OF 10 MINUTES NOT LONGER. NO OTHER CONSEQUENCES REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10766504 ↗