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
LINCOTEK MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MOVMEDIX S.A.S.
	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	303	304
Adverse Event Without Identified Device or Use Problem	109	110
Device-Device Incompatibility	74	74
Detachment of Device or Device Component	53	53
Material Split, Cut or Torn	49	49
Patient Device Interaction Problem	47	47
Positioning Failure	42	42
Device Dislodged or Dislocated	34	34
Migration	24	24
Difficult to Advance	23	23
Use of Device Problem	23	23
Entrapment of Device	19	19
Physical Resistance/Sticking	17	17
Device Slipped	17	17
Defective Device	16	16
Failure to Advance	14	14
Loosening of Implant Not Related to Bone-Ingrowth	8	8
Material Frayed	7	7
Appropriate Device Problem Term/Code Not Available	7	7
Fitting Problem	6	6
Material Twisted/Bent	5	5
Material Separation	4	4
Implant subsidence	4	4
Material Deformation	4	4
Expiration Date Error	3	3
Material Fragmentation	3	3
Fracture	3	3
Loose or Intermittent Connection	2	2
Unintended Movement	2	2
Premature Activation	2	2
Material Rupture	2	2
Mechanical Problem	2	2
Device Markings/Labelling Problem	2	2
Component Misassembled	1	1
Device Handling Problem	1	1
Material Integrity Problem	1	1
Crack	1	1
Component Missing	1	1
Inadequacy of Device Shape and/or Size	1	1
Contamination	1	1
Positioning Problem	1	1
Contamination /Decontamination Problem	1	1
Off-Label Use	1	1
Tear, Rip or Hole in Device Packaging	1	1
Insufficient Device Problem Information	1	1
Failure to Cut	1	1
Device Damaged by Another Device	1	1
Compatibility Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Delivered as Unsterile Product	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	494	495
Insufficient Information	189	189
Failure of Implant	52	52
Pain	49	49
Foreign Body In Patient	41	41
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	28	28
Unspecified Infection	24	24
Nonunion/Delayed-union Bone Fracture	22	22
Complex regional pain syndrome	14	14
Hypersensitivity/Allergic reaction	9	9
Post Operative Wound Infection	9	9
Bone Fracture(s)	8	8
Joint Dislocation	8	8
Implant Pain	6	6
Swelling/ Edema	5	5
Impaired Healing	4	5
Wound Dehiscence	4	4
Loss of Range of Motion	4	4
Bacterial Infection	4	4
Physical Asymmetry	4	4
Foreign Body Reaction	3	3
Damage to Ligament(s)	3	3
Pneumonia	3	3
Discomfort	3	3
Limb Fracture	2	2
Bone Notching	2	2
Unspecified Tissue Injury	2	2
Numbness	2	2
Necrosis	2	2
Distress	2	2
Osteolysis	2	2
Sleep Dysfunction	1	1
Rash	1	1
Inflammation	1	1
Joint Laxity	1	1
Limb Pain	1	1
Periprosthetic fracture	1	1
Irritability	1	1
Erosion	1	1
Muscle Weakness/Atrophy	1	1
Osteopenia/ Osteoporosis	1	1
Arthritis	1	1
Medical device site infection	1	1
Scar Tissue	1	1
Needle Stick/Puncture	1	1
Swelling	1	1
Fall	1	1
Skin Discoloration	1	1
Nerve Damage	1	1
Hyperresponsive to stimuli	1	1

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