NA 04.500.240Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587016863), received between Jan 30, 2017 and Oct 24, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• InjuryOct 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE BILATERAL MANDIBULAR OSTEOTOMIES, THE APPLICATION OF BILATERAL INTERNAL DISTRACTION DEVICES, AND LEFT ANTERIOR HARDWARE EROSION THROUGH CHIN SKIN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.3MM CURVILINEAR DISTRACTOR R40/RIGHT. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: Skin Erosion

  MAUDE report 15657977 ↗
• MalfunctionAug 4, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH A 1.3MM CURVILINEAR DISTRACTOR ON (B)(6) 2017. SURGEON STATES IT WAS NECESSARY TO OVER-ADVANCE THE DISTRACTOR IN ORDER TO OBTAIN FULL DISTRACTION DISTANCE. DEVICE WAS UTILIZED TO COMPLETE THE TREATMENT PLAN AND WAS REMOVED AS PLANNED ON (B)(6) 2017. SURGEON STATED THE DISTRACTOR TAB THAT PREVENTS REVERSING APPEARS TO BE DEFLECTED OUT OF THE WAY PREVENTING IT FROM ENGAGING. CONCOMITANT DEVICES REPORTED: ACTIVATION INSTRUMENT FOR CURVILINEAR DISTRACTOR (PART 03.500.016, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 1.3MM CURVILINEAR DISTRACTOR/RIGHT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6767405 ↗
• MalfunctionJan 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT TWO (2) 1.3 MM CURVILINEAR DISTRACTORS RIGHT SIDE AND ONE (1) 1.3 MM CURVILINEAR DISTRACTOR LEFT SIDE MALFUNCTIONED INTRAOPERATIVELY CAUSING A 25 MINUTE SURGICAL DELAY. A PATIENT WITH A TRACHEOSTOMY UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2017 TO TREAT A BLOCKED AIRWAY. DURING TESTING OF THE FIRST RIGHT AND LEFT SIDE DISTRACTOR DEVICES PRIOR TO INSERTION INTO THE PATIENT, THE TRACKS WERE NOT PROPERLY BACKING UP (CLOSING) AFTER BEING ADVANCED. THERE WAS AN ENORMOUS AMOUNT OF RESISTANCE THAT WAS NOT NORMAL. THESE TWO (2) DEVICES WERE NOT IMPLANTED IN THE PATIENT. ANOTHER RIGHT DISTRACTOR WAS IMPLANTED. ADVANCING FORWARD WAS FINE BUT THERE WAS DIFFICULTY GOING BACKWARDS. A LEFT DISTRACTOR WAS THEREFORE INSERTED INTO THE PATIENT. THERE WAS NO ALLEGATION OF COMPLAINT AGAINST THE SECOND LEFT DISTRACTOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS STABLE. THIS REPORT IS 1 OF 3 FOR COM-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6286461 ↗