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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device filler, bone void, non-alterable compound for cranioplasty
Definition A nonalterable cranial bone void filler is a device that is created from patient-specific computerized tomography (CT) imaging data and intended to fill bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton, and are not intrinsic to the stability of the bony structure. The materials used (e.g., metals, polyether ether ketone (PEEK), etc.) in the construction of the nonalterable cranial bone void fillers are not resorbable and cannot be altered or reshaped at the time of surgery or after implantation without changing the chemical behavior of the material.
Product CodePJN
Regulation Number 882.5330
Device Class 2


Premarket Reviews
ManufacturerDecision
OSSDSIGN AB
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequacy of Device Shape and/or Size 1 1
Device Contaminated at the User Facility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

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