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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, alterable compound for cranioplasty
Regulation Description Preformed alterable cranioplasty plate.
Definition An alterable cranial bone void filler is a device intended to be a bone substitute for the replacement of 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 device is constructed from a material (e.g., calcium, polymer synthetic-based, etc.) that can be reshaped or altered at the time of surgery or after implantation without changing the chemical behavior of the material.
Product CodePJM
Regulation Number 882.5320
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1 1

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