NA 04.315.125Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10887587015668), received between Nov 18, 2020 and Jan 27, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K060138, K080153, K162594, K170818); they may or may not involve this specific model.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE TWO BROKEN EXTENSION ARMS. WHILE USING IN A CASE THE DAY BEFORE, THE SPRING FINGERS WOULD NOT RELEASE FROM INSIDE THE EXTENSION ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191294 ↗
• MalfunctionJan 27, 2026Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE TWO BROKEN EXTENSION ARMS. WHILE USING IN A CASE THE DAY BEFORE, THE SPRING FINGERS WOULD NOT RELEASE FROM INSIDE THE EXTENSION ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191289 ↗
• MalfunctionJan 17, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON DECEMBER 28, 2023, FOUR ITEMS OUT OF THE PACKAGES WERE NOT WORKING CORRECTLY. THE THREADS ON DISTRACTOR BODIES APPEARED TO BE CROSS-THREADED AND WOULD NOT PROPERLY OPEN AND CLOSE. THESE WERE NOT USABLE FOR CASES. THE ISSUE WAS DISCOVERED DURING INSPECTION AND RESTOCKING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE REMOVABLE EXTENSION ARM-FLEX 30MM FOR CMF DISTRACTOR. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18527303 ↗
• MalfunctionJan 17, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2023, FOUR ITEMS OUT OF THE PACKAGES WERE NOT WORKING CORRECTLY. THE THREADS ON DISTRACTOR BODIES APPEARED TO BE CROSS-THREADED AND WOULD NOT PROPERLY OPEN AND CLOSE. THESE WERE NOT USABLE FOR CASES. THE ISSUE WAS DISCOVERED DURING INSPECTION AND RESTOCKING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE REMOVABLE EXTENSION ARM-FLEX 30MM FOR CMF DISTRACTOR. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18527292 ↗
• MalfunctionOct 20, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6),2023. THERE IS A INCIDENT THERE MANDIBLE DISTRACTOR CASE WITH A CMF EXTRACTION SET 30MM FLEXIBLE EXTENSION ARM PART NUMBER 04.315.125 THAT WAS MALFUNCTION AND HAPPENED FOR FOUR OF THE DEVICES IN THAT TRAY. ISSUE OCCURRED DURING SURGERY BUT NO DIRECT PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REMOVABLE EXT ARM-FLEX 30 FOR CMF DISTR. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17974936 ↗
• MalfunctionOct 20, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6),2023. THERE IS A INCIDENT THERE MANDIBLE DISTRACTOR CASE WITH A CMF EXTRACTION SET 30MM FLEXIBLE EXTENSION ARM PART NUMBER 04.315.125 THAT WAS MALFUNCTION AND HAPPENED FOR FOUR OF THE DEVICES IN THAT TRAY. ISSUE OCCURRED DURING SURGERY BUT NO DIRECT PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REMOVABLE EXT ARM-FLEX 30 FOR CMF DISTR THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17974928 ↗
• MalfunctionOct 20, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2023. THERE IS A INCIDENT THERE MANDIBLE DISTRACTOR CASE WITH A CMF EXTRACTION SET 30MM FLEXIBLE EXTENSION ARM PART NUMBER 04.315.125 THAT WAS MALFUNCTION AND HAPPENED FOR FOUR OF THE DEVICES IN THAT TRAY. ISSUE OCCURRED DURING SURGERY BUT NO DIRECT PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REMOVABLE EXT ARM-FLEX 30 FOR CMF DISTR THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17974924 ↗
• InjuryApr 12, 2023Mechanical Jam; Mechanical Jam

  IT WAS FURTHER REPORTED THAT: ON (B)(6)2023, A SURGERY WAS PERFORMED ON A TODDLER (ONE AND A HALF YEARS OLD) DURING WHICH THE CURVILINEAR DISTRACTION SYSTEM WAS USED ON BOTH SIDES OF THE PATIENT'S JAW. IN THE EXAMINATION PERFORMED BY THE SURGEON AT THE END OF THE SURGERY, THE SYSTEM OPERATED INTACT ON BOTH SIDES OF THE JAW (RIGHT AND LEFT). ON THE SECOND DAY AFTER THE SURGERY, WHILE THE PATIENT WAS HOSPITALIZED, THE FIRST DISTRACTION WAS PERFORMED. ACCORDING TO THE SURGEON, THIS DISTRACTION WAS SUCCESSFUL, AND NO PROBLEMS WERE NOTICED WITH THE DISTRACTION AND THE PATIENT WAS DISCHARGED HOME AFTER THE PATIENT'S MOTHER WAS INSTRUCTED HOW TO CONTINUE PERFORMING THE DISTRACTIONS AT HOME. ON (B)(6)2023, THE FIRST FOLLOW-UP TOOK PLACE, DURING WHICH AN ADDITIONAL DISTRACTION OF THE DEVICE WAS PERFORMED ON BOTH SIDES OF THE JAW. DISTRACTION WAS INTACT AND NO PROBLEMS WITH SYSTEM WERE OBSERVED. ON (B)(6)2023, A SECOND FOLLOW-UP TOOK PLACE, DURING WHICH AN X-RAY WAS TAKEN; THERE WAS OBSERVED EVIDENCE OF JAW DISTRACTION ON THE RIGHT SIDE, BUT NOT ON THE LEFT SIDE. IN ADDITION, SLIGHT SWELLING WAS REPORTED ON THE LEFT SIDE OF THE PATIENT'S JAW. DURING THIS FOLLOW-UP, THE SURGEON MADE SURE THAT

  Patient problems: Failure of Implant

  MAUDE report 16728477 ↗
• InjuryNov 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE FLEXIBLE EXTENSION ARM WOULD NOT DISENGAGE FROM CMF DISTRACTOR BODY DURING DISTRACTION OSTEOGENESIS REMOVAL OF EXTENSION ARMS AFTER COMPLETION OF ACTIVATION PHASE. THE SURGEON TOOK THE PATIENT BACK INTO THE OPERATING ROOM TO REMOVE THE EXTENSION ARM ONLY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. THE PROCEDURE AND PATIENT OUTCOMES WERE UNKNOWN. THIS REPORT IS FOR ONE (1) REMOVABLE EXTENSION ARM-FLEX 30MM FOR CMF DISTRACTOR. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10864284 ↗
• InjuryNov 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE FLEXIBLE EXTENSION ARM WOULD NOT DISENGAGE FROM CMF DISTRACTOR BODY DURING DISTRACTION OSTEOGENESIS REMOVAL OF EXTENSION ARMS AFTER COMPLETION OF ACTIVATION PHASE. THE SURGEON TOOK THE PATIENT BACK INTO THE OPERATING ROOM TO REMOVE THE EXTENSION ARM ONLY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. THE PROCEDURE AND PATIENT OUTCOMES WERE UNKNOWN. THIS REPORT IS FOR ONE (1) REMOVABLE EXTENSION ARM-FLEX 30MM FOR CMF DISTRACTOR. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10864153 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060138, K080153, K162594, K170818. One submission often covers many models, so check the product and lot details in each record.

• Z-2148-2014 · Apr 16, 2014 · Terminated
  DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
• Z-1726-2013 · Jun 12, 2013 · Terminated
  Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-tra