NA 04.315.104Recalls & reported problems
Synthes GmbH · REMOVABLE EXTENSION ARM-RIGID 20MM FOR CMF DISTRACTOR · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587015637), received between Oct 25, 2024 and Oct 25, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K060138, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 15 PATIENTS WHO UNDERWENT SURGERY USING CMF-D DISTRACTOR (CRANIAL INDICATION) AT (B)(6) HOSPITAL OF (B)(6). PATIENT C14, 9-MONTH-OLD FEMALE: THE PATIENT UNDERWENT 1. PLACE RIGHT AND LEFT CRANIAL DISTRACTORS, 40 MM LENGTH, 2. PLATE OSTEOSYNTHESIS, RIGHT AND LEFT LAMBDOID SUTURES, 3. BARREL STAVE OSTEOTOMIES, CRANIAL BASE. POST OP COMPLICATION INCLUDED RIGHT DISTRACTOR ARM FELL A MONTH POST-SURGERY. PARENT WAS ABLE TO REATTACH AND CONTINUE TURNING. IMPLANT(S) INVOLVED: 20MM RIGID EXTENSION ARM.
Patient problems: Insufficient Information
MAUDE report 20532497 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K060138, K162594, K170818. 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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