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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde
Definition Device type: Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction, revision spine surgery, autograft not available or feasible - replacement for autograft bone in patients where autograft is unavailable or not feasible to harvest. Not feasible to harvest is intended to means presence of a condition where normal bone metabolism would be expected to prevent healing, e.G., smokers and diabetics. Revision spine surgery to treat pseudarthrosis.
Product CodeOJZ
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2015 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Biotech II Mar-18-2011
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