NA 04.315.503Recalls & reported problems
Synthes GmbH · 1.3MM MESH FOOT C-TYPE FOR CMF DISTRACTOR · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587016245), received between Aug 19, 2022 and Oct 15, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K060138, K162594); 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Break; Break
IT WAS REPORTED THAT THE PATIENT'S DISTRACTORS FOOTPLATE BROKE TODAY AFTER THE DISTRACTOR WAS ACTIVATED. THE DISTRACTORS WERE IMPLANTED ON (B)(6) 2025. PATIENT WAS REVISED ON (B)(6) 2025.
Patient problems: Insufficient Information
MAUDE report 23279986 ↗MalfunctionAug 19, 2022Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CMF DISTRACTION SYSTEM, ONE OF THE FOOTPLATES WAS BROKEN ON EXPLANT AND USED WITH THE DISTRACTED BODY IN CONJUNCTION WITH THE PART THAT WAS EXPLANTED TO THE PATIENT AND UPON EXPLANATION THE FOOTPLATE A WAS BROKEN OFF. THERE WAS NO SURGICAL DELAY, PATIENT WAS FINE AND HEALTHY. THIS REPORT INVOLVES ONE (1) 1.3MM MESH FOOT C-TYPE FOR CMF DISTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15260327 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K060138, K162594. One submission often covers many models, so check the product and lot details in each record.
- Z-2148-2014 · Apr 16, 2014 · TerminatedDePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
- Z-1726-2013 · Jun 12, 2013 · TerminatedSynthes 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
Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices
- DISTRACTION, INTERNAL 51-405-42-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR20 reports
- LEVEL ONE CMF 50-760-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR18 reports
- DISTRACTION, INTERNAL 51-563-30-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR13 reports
- LEVEL ONE CMF 50-797-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR13 reports
- LEVEL ONE CMF 50-777-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR11 reports
- DISTRACTION, INTERNAL 51-401-91-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- NA 04.315.125Synthes GmbH · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- DISTRACTION, INTERNAL 51-526-30-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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