TPLC - Total Product Life Cycle

• Device: stimulator, invasive bone growth
• Product Code: LOE
• Device Class: 3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
0	0	1	2	4	2	4	4	4	16	4	0	2	4	0	0

MDR Year	MDR Reports	MDR Events
2014	3	3
2015	6	6
2016	5	5
2017	5	5
2018	7	7
2019	10	10
2020	5	5
2021	3	3
2023	2	2
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	16	16
Appropriate Term/Code Not Available	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Patient-Device Incompatibility	7	7
Device-Device Incompatibility	2	2
Failure to Power Up	2	2
Material Separation	1	1
Unexpected Therapeutic Results	1	1
Microbial Contamination of Device	1	1
Break	1	1
Material Discolored	1	1
Disconnection	1	1
Migration or Expulsion of Device	1	1
Nonstandard Device	1	1
Detachment of Device or Device Component	1	1
Device Operates Differently Than Expected	1	1
Migration	1	1
Inaccurate Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	19	19
No Code Available	8	8
Unspecified Infection	7	7
No Known Impact Or Consequence To Patient	6	6
No Information	6	6
Swelling	4	4
Abscess	2	2
Test Result	2	2
Insufficient Information	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Local Reaction	1	1
Sepsis	1	1
Skin Irritation	1	1
Cyst(s)	1	1
Headache	1	1
Failure of Implant	1	1
Itching Sensation	1	1
Muscle Spasm(s)	1	1
Necrosis	1	1
Vertigo	1	1
Dizziness	1	1
No Consequences Or Impact To Patient	1	1
Therapeutic Response, Decreased	1	1
Discomfort	1	1
Injury	1	1
Reaction	1	1
Post Operative Wound Infection	1	1
Electric Shock	1	1
Lethargy	1	1
Foreign Body In Patient	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