TPLC - Total Product Life Cycle

show TPLC since

Device	appliance, fixation, nail/blade/plate combination, multiple component, metal composite
Regulation Description	Single/multiple component metallic bone fixation appliances and accessories.
Product Code	LXT
Regulation Number	888.3030
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	30	32
Mechanical Problem	20	20
Break	18	18
Device-Device Incompatibility	15	15
Appropriate Device Problem Term/Code Not Available	10	10
Migration or Expulsion of Device	7	7
Connection Problem	5	5
Fracture	4	4
Tear, Rip or Hole in Device Packaging	4	4
Crack	4	4
Material Deformation	4	4
Packaging Problem	3	3
Device Contaminated During Manufacture or Shipping	2	2
Detachment of Device or Device Component	2	2
Malposition of Device	1	1
Device Damaged Prior to Receipt by User	1	1
Unsealed Device Packaging	1	1
Loss of Osseointegration	1	1
Device Slipped	1	1
Migration	1	1
Mechanical Jam	1	1
Insufficient Device Problem Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	51	51
Failure of Implant	18	18
No Code Available	13	13
Nonunion/Delayed-union Bone Fracture	10	11
Pain	10	10
No Known Impact Or Consequence To Patient	7	7
Insufficient Information	6	8
Unspecified Infection	6	6
No Patient Involvement	5	5
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	5	5
Loss of Range of Motion	2	3
Injury	2	2
No Consequences Or Impact To Patient	2	2
Bone Fracture(s)	2	2
Post Operative Wound Infection	2	2
Unspecified Tissue Injury	2	2
Swelling/ Edema	1	1
Impaired Healing	1	1
Osteopenia/ Osteoporosis	1	1
Muscular Rigidity	1	1
Osteolysis	1	1
Malunion of Bone	1	1
Nerve Damage	1	1
Skin Infection	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Physical Asymmetry	1	1
Fluid Discharge	1	1
Discomfort	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.	II	Jun-28-2022