TPLC - Total Product Life Cycle

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Device	washer, bolt nut
Regulation Description	Single/multiple component metallic bone fixation appliances and accessories.
Product Code	HTN
Regulation Number	888.3030
Device Class	2

Premarket Reviews
Manufacturer	Decision
ACUMED, LLC
	SUBSTANTIALLY EQUIVALENT	2
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	5
CC-INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
FUSION ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
GM DOS REIS INDUSTRIA E COMERCIO LTDA.
	SUBSTANTIALLY EQUIVALENT	1
IN2BONES USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPAEDIC IMPLANT COMPANY
	SUBSTANTIALLY EQUIVALENT	1
TRIMED, INC.
	SUBSTANTIALLY EQUIVALENT	2
VILEX, LLC
	SUBSTANTIALLY EQUIVALENT	2
WRIGHT MEDICAL TECHNOLOGY, INC. (STRYKER CORPORATION)
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	304	305
Adverse Event Without Identified Device or Use Problem	92	93
Device-Device Incompatibility	72	72
Material Split, Cut or Torn	45	45
Detachment of Device or Device Component	44	44
Patient Device Interaction Problem	39	39
Device Dislodged or Dislocated	33	33
Positioning Failure	31	31
Migration	22	22
Difficult to Advance	22	22
Use of Device Problem	21	21
Entrapment of Device	19	19
Device Slipped	18	18
Defective Device	16	16
Physical Resistance/Sticking	13	13
Failure to Advance	11	11
Appropriate Term/Code Not Available	10	10
Loosening of Implant Not Related to Bone-Ingrowth	8	8
Material Frayed	6	6
Material Twisted/Bent	6	6
Fitting Problem	6	6
Material Separation	5	5
Material Deformation	4	4
Material Fragmentation	3	3
Expiration Date Error	3	3
Device Markings/Labelling Problem	3	3
Material Rupture	3	3
Unintended Movement	2	2
Output Problem	2	2
Premature Activation	2	2
Mechanical Problem	2	2
Loose or Intermittent Connection	2	2
Activation, Positioning or Separation Problem	2	2
Patient-Device Incompatibility	2	2
Fracture	2	2
Tear, Rip or Hole in Device Packaging	1	1
Dull, Blunt	1	1
Component Missing	1	1
Unstable	1	1
Delivered as Unsterile Product	1	1
Unsealed Device Packaging	1	1
Inadequacy of Device Shape and/or Size	1	1
Device Difficult to Setup or Prepare	1	1
Off-Label Use	1	1
Difficult to Remove	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Compatibility Problem	1	1
Material Integrity Problem	1	1
Difficult to Open or Close	1	1
Device Damaged by Another Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	437	438
Insufficient Information	179	179
Failure of Implant	50	50
Pain	43	43
Foreign Body In Patient	36	36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	28	28
Unspecified Infection	23	23
Non-union Bone Fracture	21	21
Post Operative Wound Infection	9	9
Bone Fracture(s)	8	8
Joint Dislocation	7	7
Hypersensitivity/Allergic reaction	7	7
Swelling/ Edema	5	5
Impaired Healing	4	5
Implant Pain	4	4
Loss of Range of Motion	4	4
Physical Asymmetry	4	4
Damage to Ligament(s)	3	3
Wound Dehiscence	3	3
Discomfort	3	3
Necrosis	2	2
Distress	2	2
Foreign Body Reaction	2	2
Osteolysis	2	2
Unspecified Tissue Injury	2	2
Limb Fracture	2	2
Increased Sensitivity	1	1
Device Embedded In Tissue or Plaque	1	1
Arthritis	1	1
Irritability	1	1
Bacterial Infection	1	1
Erosion	1	1
Joint Laxity	1	1
Fall	1	1
Scar Tissue	1	1
Numbness	1	1
Nerve Damage	1	1
Swelling	1	1
Needle Stick/Puncture	1	1
Skin Discoloration	1	1
Osteopenia/ Osteoporosis	1	1
Muscle Weakness	1	1
Sleep Dysfunction	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	TriMed Inc.	II	Feb-07-2023