NA 04.315.132Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587015682), received between Jan 2, 2019 and Sep 24, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Detachment of Device or Device Component

  It was reported the Flexible Extension Arm separated from the Curvilinear Distractor Implant two weeks post-operatively during activation. The procedure was completed with no significant delay or patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884222 ↗
• MalfunctionDec 9, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019 DURING A MANDIBLE DISTRACTION FOR A CORRECTIVE JAW SURGERY THE REMOVABLE EXTENSION ARM-FLEX FOR A CURVILINEAR DISTRACTOR WAS BROKE WHILE TRYING TO ENGAGE THE DISTRACTION ARM WITH THE DISTRACTOR. THE SURGERY WAS DELAYED SIXTY (6) MINUTES. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. CONCOMITANT DEVICES: UNK - DISTRACTOR (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) REMOVABLE EXTENSION ARM-FLEX 60MM FOR CMF DISTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9438863 ↗
• InjuryJan 2, 2019Mechanical Jam; Naturally Worn; Mechanical Jam; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A REVISION OF MANDIBULAR DISTRACTION BECAUSE THE CURVILINEAR DISTRACTOR STOPPED DISTRACTING SOMEWHERE BETWEEN 20-25MM. THE RIGHT ADVANCED FARTHER, DESPITE A SLOWER RATE OF DISTRACTION, AS COMPARED TO THE LEFT. THE REMOVABLE EXTENSION ARM-FLEXIBLE WAS IDENTIFIED TO BE STUCK AND COULD NOT BE DISASSEMBLED FROM THE CURVILINEAR DISTRACTOR. THE SURGEON REPLACED THE OLD DISTRACTOR, WITH A NEW ONE, TO FINISH THE DISTRACTION ON THE MANDIBLE. ORIGINAL IMPLANT DATE IS ON (B)(6) 2018. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) REMOVABLE EXTENSION ARM-FLEX 60MM FOR CMF DISTRACTOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8210048 ↗

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