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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cranial distraction system
Regulation Description Preformed nonalterable cranioplasty plate.
Definition 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.
Product CodePBJ
Regulation Number 882.5330
Device Class 2


Premarket Reviews
ManufacturerDecision
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 8 8
2021 1 1
2022 1 1
2023 1 1
2024 2 2
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6 6
Device-Device Incompatibility 5 5
Adverse Event Without Identified Device or Use Problem 3 3
Activation Problem 2 2
Patient-Device Incompatibility 1 1
Material Deformation 1 1
Failure to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Impaired Healing 7 7
Failure of Implant 3 3
No Code Available 3 3
Insufficient Information 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Discomfort 1 1
Pain 1 1

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