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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, invasive bone growth
Product CodeLOE
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
4 16 4 0 2 2

MDR Year MDR Reports MDR Events
2017 5 5
2018 7 7
2019 10 10
2020 5 5
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 11 11
Appropriate Term/Code Not Available 7 7
Adverse Event Without Identified Device or Use Problem 5 5
Patient-Device Incompatibility 4 4
Device-Device Incompatibility 2 2
Failure to Power Up 2 2
Unexpected Therapeutic Results 1 1
Microbial Contamination of Device 1 1
Material Discolored 1 1
Disconnection 1 1
Migration or Expulsion of Device 1 1
Nonstandard Device 1 1
Migration 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 13 13
Unspecified Infection 6 6
No Code Available 6 6
No Information 4 4
No Known Impact Or Consequence To Patient 2 2
Swelling 2 2
No Consequences Or Impact To Patient 1 1
Reaction 1 1
Post Operative Wound Infection 1 1
Lethargy 1 1
Test Result 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Itching Sensation 1 1
Muscle Spasm(s) 1 1
Necrosis 1 1
Sepsis 1 1
Skin Irritation 1 1
Abscess 1 1
Headache 1 1
Failure of Implant 1 1

Recalls
Manufacturer Recall Class Date Posted
1 EBI Patient Care, Inc. I May-26-2017
2 Zimmer Biomet, Inc. I Nov-02-2018
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