TPLC - Total Product Life Cycle

• Device: prosthesis, toe, constrained, polymer
• Product Code: KWH
• Regulation Number: 888.3720
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BRM EXTREMITIES
	SUBSTANTIALLY EQUIVALENT	1
FUSION ORTHOPEDICS, LLC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	15	15
2020	8	8
2021	5	5
2022	5	5
2023	6	6
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	16	16
Break	8	8
Fracture	6	6
Material Integrity Problem	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Device Dislodged or Dislocated	2	2
Migration or Expulsion of Device	1	1
Crack	1	1
Patient-Device Incompatibility	1	1
Degraded	1	1
Material Fragmentation	1	1
Failure to Align	1	1
No Apparent Adverse Event	1	1
Migration	1	1
Appropriate Term/Code Not Available	1	1
Inaccurate Information	1	1
Loss of Osseointegration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	9	9
Failure of Implant	8	8
Unspecified Infection	4	4
Pain	3	3
Patient Problem/Medical Problem	2	2
No Code Available	2	2
Implant Pain	2	2
Post Operative Wound Infection	2	2
Osteolysis	2	2
No Consequences Or Impact To Patient	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Rheumatoid Arthritis	1	1
Hypersensitivity/Allergic reaction	1	1
Inadequate Osseointegration	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Bone Fracture(s)	1	1
Osteopenia/ Osteoporosis	1	1
Foreign Body Reaction	1	1
Injury	1	1
Foreign Body In Patient	1	1
Discomfort	1	1
No Patient Involvement	1	1
Muscular Rigidity	1	1
Fall	1	1
Joint Laxity	1	1