NA 04.315.127Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587015675), received between Feb 10, 2020 and Aug 27, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE EXTENSION ARM DISENGAGED FROM THE DISTRACTOR OF THE CMF-DISTRACTOR POST-SURGERY. IT WAS REPORTED ON (B)(6) 2020 THAT THE PATIENT UNDERWENT REVISION SURGERY TO REIMPLANT ANOTHER DEVICE. THE PATIENT IS REPORTED AS DOING WELL. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) REMOVABLE EXTENSION ARM-FLEX 40MM FOR CMF DISTRACTOR. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10463204 ↗
• MalfunctionFeb 10, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE IMPLANT DISTRACTION DEVICE DID NOT REALLY WORK LIKE IT WAS SUPPOSED TO. THERE WAS SOME PATIENT ERROR. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND THE OUTCOME ARE UNKNOWN. THIS IS REPORT 03 OF 04 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9687114 ↗
• MalfunctionFeb 10, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE IMPLANT DISTRACTION DEVICE DID NOT REALLY WORK LIKE IT WAS SUPPOSED TO. THERE WAS SOME PATIENT ERROR. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND THE OUTCOME ARE UNKNOWN. THIS IS REPORT 04 OF 04 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9687050 ↗

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