NA 488.076Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587056128), received between Jan 19, 2021 and Jan 19, 2021 — classified as 1 malfunction.

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.

• MalfunctionJan 19, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A MAXILLA DISTRACTION ON (B)(6) 2020, THE ALVEOLAR DISTRACTOR BROKE DURING THE CASE. UPON OPENING THE DISTRACTOR/OSTEOTOMY, THE DISTRACTOR GEAR BROKE, THUS RENDERING IT UNUSABLE. THE SURGEON HAS TO FORCE THE REMOVAL OF THE BROKEN DISTRACTOR AND REIMPLANT A 12MM DISTRACTOR. IT WAS ALSO MENTIONED THAT DUE TO THE REPORTED ISSUE, TWO (2) EMERGENCY SCREWS HAD TO BE USED BECAUSE THE PREVIOUS SCREW HOLES BECAME STRIPPED OUT WHEN TRYING TO PLACE THE SCREWS BACK IN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A 15 MINUTES OR LESS SURGICAL DELAY REPORTED. PATIENT STATUS WAS GOOD. CONCOMITANT DEVICE REPORTED: 2.0 MM TITANIUM EMERGENCY SCREWS (PART # 400.276E, LOT # UNKNOWN, QUANTITY 2). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT INVOLVES ONE (1) TI ALVEOLAR DISTRACTOR WITH STRAIGHT PLATE 16MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11194913 ↗