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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device anchor, suture, bone fixation, metallic
Definition This device is indicated for attaching suture into bone for suspension of the nasal valve and for attaching suture into bone at the lower orbital rim.
Product CodeNOV
Regulation Number 888.3030
Device Class 2

MDR Year MDR Reports MDR Events
2017 3 3
2018 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2 2
Break 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Osteolysis 2 2
No Code Available 1 1
Failure of Implant 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Sep-07-2016
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