ORTHOLOC™ 2 9914PK01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889797076869), received between Oct 20, 2021 and Nov 30, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT TWO JOINT PREP KITS AND THE 2.5 DRILLS BOTH GOT STUCK IN THE DRILL GUIDE. SURGEON WAS EXTRA CAREFUL AFTER THE FIRST ONE GOT STUCK AND THE SECOND DRILL STILL GOT STUCK IN THE SECOND DRILL GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15887041 ↗
• MalfunctionNov 30, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THERE WERE TWO JOINT PREP KITS AND THE 2.5 DRILLS BOTH GOT STUCK IN THE DRILL GUIDE. THE SURGEON WAS EXTRA CAREFUL AFTER THE FIRST ONE GOT STUCK AND THE SECOND DRILL STILL GOT STUCK IN THE SECOND DRILL GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15887007 ↗
• MalfunctionOct 20, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE OSTEOTOME IN THE KIT WAS DULL. IT DID NOT SCRAPE ANY BONE AT ALL. IT ALSO SEEMED LIKE A DIFFERENT SHAPE, A LITTLE MORE THICK AND ALSO DID NOT HAVE THE JAGGED LASER MARK ON THE BACK OF THE OSTEOTOME. NEEDED TO OPEN HOSPITAL OWNED TRAY. THIS DELAYED THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12667351 ↗