ORTHOLOC 3Di 5820MPX1LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840420187031), received between Sep 9, 2021 and Oct 16, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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.

• InjuryOct 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE ORTHOLOC CROSSCHECK PLATE BROKE SOMETIME AFTER THE INITIAL SURGERY WAS COMPLETED RESULTING IN A NON-UNION. THE PATIENT WAS BROUGHT BACK, AND THE SURGEON HAD TO REMOVE THE PLATE AND REPLACED IT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 23318723 ↗
• MalfunctionJul 19, 2024Device Damaged Prior to Receipt by User; Component Missing; Device Damaged Prior to Receipt by User; Component Missing

  AS REPORTED: "WHEN WE OPENED UP THE SET IN THEATRE THERE WERE 2X RIGHT MTP CROSSCHECK PLATES (5820MPX1R) AND NO LEFT SIDE (5820MPX1L). THERE WAS A RIGHT SIDED PLATE IN WHERE THE LEFT SHOULD BE. THE PATIENT WE WERE DOING WAS A LEFT. LUCKILY WE WERE ABLE TO BAIL OUT TO A STANDARD ORTHOLOC MTP PLATE. THIS HOWEVER WAS NOT THE SURGEONS PRIMARY PLAN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19780238 ↗
• MalfunctionSep 9, 2021Component Missing; Component Missing

  THE CUSTOMER REPORTED THAT THE LOAN CROSSCHECK MODULE DID NOT CONTAIN ANY OF THE REQUIRED MTP CROSSCHECK PLATES. THIS WAS THE PLATE THAT WAS NEEDED FOR THIS PROCEDURE. THE SURGEON COULD NOT USE HIS PREFERRED IMPLANT. A DIFFERENT IMPLANT WAS USED TO COMPLETE THE CASE. THE SURGEON FURTHER MENTIONED THE PATIENT MAY SUFFER FROM SKIN IRRITATION GOING FORWARDS BY USING A THICKER PLATE IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450203 ↗