NA 288.027Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587029375), received between Feb 13, 2023 and Nov 25, 2025 — classified as 1 injury, 2 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 16, 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 25, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON PRE-BENT THE DISTRACTOR ON A BONE MODEL PRIOR TO SURGERY AND THIS DISTRACTOR BODY BROKE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643650 ↗
• InjurySep 23, 2024Break; Break

  IT WAS REPORTED THAT DURING A MAXILLARY DISTRACTION CASE THE SURGEON HAD IMPLANTED MOST OF THE PATIENT¿S LEFT DISTRACTOR CONSTRUCT WHEN THEY NOTICED WHAT LOOKED LIKE A BAR OR SMALL PIECE OF WIRE IN THE WOUND. ORIGINALLY IT WAS THOUGHT TO BE A PIECE OF THE PATIENT¿S BRACES OR ORTHODONTICS; IT WAS RETRIEVED AND SET IS ASIDE ON THE BACK TABLE. WHILE PREPARING THE SCREW HOLES FOR THE LAST FEW SCREWS, THE ACTIVATION HEX END PIECE OF THE DISTRACTOR BODY DISENGAGED FROM THE DISTRACTOR BODY. IT WAS RETRIEVED FROM THE WOUND AND THEN REALIZED THE BAR PIECE FOUND EARLIER WAS THE PIN THAT HOLDS OR FUSES THE HEX END TO THE DISTRACTOR BODY. BOTH PIECES WERE EASILY AND SAFELY RETRIEVED AND THE CONSTRUCT WAS REMOVED, TAKEN APART, AND REBUILT WITH A NEW DISTRACTOR BODY FROM THE SET. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN (10) MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20282009 ↗
• MalfunctionFeb 13, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM DENMARK REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE MAXILLARY DISTRACTOR BODY WAS BEING PREPARED FOR SURGERY, PRE-OP, OUTSIDE OF THE OPERATING ROOM. WHEN ASSEMBLING THE APPARATUS, IT WAS NOT POSSIBLE TO SCREW THE MACHINE SCREW INTO THE DISTRACTOR BODY. THERE WAS NO PATIENT INTERACTION. THE SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER DISTRACTOR. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MAXILLARY DISTRACTOR BODY 20MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362756 ↗