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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
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
KLS MARTIN LP
  SUBSTANTIALLY EQUIVALENT 1
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED LP
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES USA PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 8 8
2021 1 1
2022 1 1
2023 1 1

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Impaired Healing 8 8
No Code Available 3 3
Failure of Implant 3 3
No Clinical Signs, Symptoms or Conditions 1 1

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