TPLC - Total Product Life Cycle

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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	28	30
Mechanical Problem	20	20
Device-Device Incompatibility	16	16
Break	11	12
Connection Problem	5	5
Crack	4	4
Material Deformation	4	4
Tear, Rip or Hole in Device Packaging	4	4
Device Contaminated During Manufacture or Shipping	2	2
Packaging Problem	2	2
Fracture	2	2
Device Slipped	1	1
Malposition of Device	1	1
Unsealed Device Packaging	1	1
Material Integrity Problem	1	1
Shipping Damage or Problem	1	1
Material Too Rigid or Stiff	1	1
Detachment of Device or Device Component	1	1
Appropriate Term/Code Not Available	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	49	49
Pain	8	8
Non-union Bone Fracture	7	8
Unspecified Infection	6	6
Insufficient Information	6	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
No Patient Involvement	4	4
Failure of Implant	3	3
Bone Fracture(s)	2	2
Post Operative Wound Infection	2	2
Loss of Range of Motion	2	3
Unspecified Tissue Injury	2	2
Impaired Healing	1	1
Skin Infection	1	1
Osteopenia/ Osteoporosis	1	1
Muscular Rigidity	1	1
Nerve Damage	1	1
Discomfort	1	1
Osteolysis	1	1
Malunion of Bone	1	1
Swelling/ Edema	1	1
Physical Asymmetry	1	1
Hemorrhage/Bleeding	1	1

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