PBJClass IIImplantLife-sustaining

Cranial Distraction System

Neurology · 21 CFR 882.5330

A cranial distraction system is a metal device intended to establish osteodistraction and bone growth in the skull. The bone segments are attached to the plate with screws to prevent movement of the segments.

MDR events18All time

Recalls0All time

Registered firms12Currently listed

510(k) clearances6All time

Recent MDR events

18 adverse event reports on file

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BC DISTRACTOR BODY END ACT 35MM FOR CMF DISTRACTORAug 7, 2025
MalfunctionSynthes Gmbh8030965-2025-08113
DISTRACTION CRANIOXPANDFeb 26, 2025
InjuryKls Martin Se & Co. Kg9610905-2025-00022
2.0MM MESH FOOT A-TYPE FOR CMF DISTRACTORJan 31, 2025
MalfunctionSynthes Gmbh8030965-2025-01155
REMOVABLE EXTENSION ARM-FLEX 60MM FOR CMF DISTRACTORJan 8, 2025
MalfunctionSynthes Gmbh8030965-2025-00254
UNK - DISTRACTOR IMPLANTS: CRANIOMAXILLOFACIALOct 25, 2024
InjurySynthes Gmbh8030965-2024-13214
DISTRACTIONJun 3, 2024
InjuryKls Martin Se & Co. Kg9610905-2024-00030
DISTRACTIONFeb 14, 2023
InjuryKarl Leibinger Medizintechnik Gmbh & Co. Kg9610905-2023-00001
DISTRACTIONNov 23, 2022
InjuryKarl Leibinger Medizintechnik Gmbh & Co. Kg9610905-2022-00089
DISTRACTIONJun 15, 2021
InjuryKarl Leibinger Medizintechnik Gmbh & Co. Kg9610905-2021-00046
REMOVABLE EXTENSION ARM-FLEX 30MM FOR CMF DISTRACTORNov 18, 2020
InjuryWrights Lane Synthes Usa Products Llc2939274-2020-05218

Event type breakdown

Injury15

Malfunction3

Most-reported manufacturers

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Karl Leibinger Medizintechnik Gmbh & Co. Kg9 Synthes Gmbh4 Wrights Lane Synthes Usa Products Llc3 Kls Martin Se & Co. Kg2

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

12 firms currently registered for this product code

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510(k) clearances

6 clearances for this product code

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