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
AKROS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	6
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	2
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	337	338
Adverse Event Without Identified Device or Use Problem	114	115
Device-Device Incompatibility	76	76
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	35	35
Positioning Failure	31	31
Difficult to Advance	24	24
Migration	22	22
Use of Device Problem	21	21
Device Slipped	21	21
Entrapment of Device	20	20
Defective Device	18	18
Appropriate Term/Code Not Available	14	14
Physical Resistance/Sticking	13	13
Failure to Advance	12	12
Loosening of Implant Not Related to Bone-Ingrowth	8	8
Material Twisted/Bent	7	7
Material Separation	7	7
Material Frayed	6	6
Fitting Problem	6	6
Material Deformation	4	4
Improper or Incorrect Procedure or Method	3	3
Material Rupture	3	3
Device Markings/Labelling Problem	3	3
Patient-Device Incompatibility	3	3
Expiration Date Error	3	3
Fracture	3	3
Material Fragmentation	3	3
Loose or Intermittent Connection	3	3
Activation, Positioning or Separation Problem	2	2
Premature Activation	2	2
Insufficient Information	2	2
No Apparent Adverse Event	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Unintended Movement	2	2
Therapeutic or Diagnostic Output Failure	2	2
Delivered as Unsterile Product	2	2
Mechanical Problem	2	2
Output Problem	2	2
Separation Problem	1	1
Activation Problem	1	1
Contamination	1	1
Use of Incorrect Control/Treatment Settings	1	1
Component Misassembled	1	1
Crack	1	1
Noise, Audible	1	1
Device Handling Problem	1	1
Positioning Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	446	447
Insufficient Information	185	185
Failure of Implant	62	62
Pain	53	53
Foreign Body In Patient	40	40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	29	29
Unspecified Infection	25	25
Non-union Bone Fracture	21	21
No Code Available	20	20
No Consequences Or Impact To Patient	14	14
Joint Dislocation	12	12
Bone Fracture(s)	11	11
Hypersensitivity/Allergic reaction	10	10
Post Operative Wound Infection	9	9
Injury	9	9
Osteolysis	7	7
No Known Impact Or Consequence To Patient	6	6
Swelling/ Edema	5	5
Loss of Range of Motion	5	5
Impaired Healing	4	5
Physical Asymmetry	4	4
Implant Pain	4	4
Device Embedded In Tissue or Plaque	3	3
Damage to Ligament(s)	3	3
Wound Dehiscence	3	3
Necrosis	3	3
Foreign Body Reaction	3	3
Discomfort	3	3
Distress	2	2
Bacterial Infection	2	2
Unspecified Tissue Injury	2	2
Limb Fracture	2	2
Fall	2	2
Swelling	2	2
Arthralgia	2	2
Pleural Effusion	1	1
Muscular Rigidity	1	1
No Patient Involvement	1	1
Needle Stick/Puncture	1	1
Skin Discoloration	1	1
Nerve Damage	1	1
Numbness	1	1
Osteopenia/ Osteoporosis	1	1
Muscle Weakness	1	1
Scar Tissue	1	1
Reaction	1	1
Cyst(s)	1	1
Anxiety	1	1
No Information	1	1
Fatigue	1	1

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