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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, calcium compound containing single approved aminoglycoside
Definition A resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial is a resorbable implant intended to fill bony defects of the extremities where there is an increased risk of infection. It is intended to resorb over time and be replaced by new bone. The product is intended for reduction of recurrence of chronic osteomyelitis of long bones. It is not intended to treat infection.
Product CodeQRR
Regulation Number 888.3046
Device Class 2


Premarket Reviews
ManufacturerDecision
BONESUPPORT AB
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inflammation 1 1
Implant Pain 1 1

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