TPLC - Total Product Life Cycle

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Device	pin, fixation, smooth
Regulation Description	Smooth or threaded metallic bone fixation fastener.
Product Code	HTY
Regulation Number	888.3040
Device Class	2

Premarket Reviews
Manufacturer	Decision
4WEB MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
4WEB, INC.
	SUBSTANTIALLY EQUIVALENT	1
AIRS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARMIS BIOPHARMA, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	2
BIOMET, INC.
	SUBSTANTIALLY EQUIVALENT	1
ELECTRO-SPEC, INC.
	SUBSTANTIALLY EQUIVALENT	1
IN2BONES USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
INTELIVATION
	SUBSTANTIALLY EQUIVALENT	1
LIMA CORPORATE S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
NVISION BIOMEDICAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
NVISION BIOMEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIATRICS CORP.
	SUBSTANTIALLY EQUIVALENT	2
OSSIO , LTD.
	SUBSTANTIALLY EQUIVALENT	6
PACIFIC INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	1
PARAGON 28, INC.
	SUBSTANTIALLY EQUIVALENT	1
RESTOR3D
	SUBSTANTIALLY EQUIVALENT	1
SKELETAL DYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	1
TOETAL SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
TYBER MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
XIROS, LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	419	422
Break	181	182
Fracture	86	86
Detachment of Device or Device Component	47	47
Mechanical Jam	39	39
Patient Device Interaction Problem	23	23
Material Deformation	22	22
Device-Device Incompatibility	21	21
Use of Device Problem	20	20
Migration	18	18
Material Split, Cut or Torn	18	18
Defective Device	15	15
Material Twisted/Bent	15	15
Insufficient Device Problem Information	13	13
Appropriate Device Problem Term/Code Not Available	13	13
Physical Resistance/Sticking	12	12
Activation Failure	10	10
Entrapment of Device	10	11
Device Dislodged or Dislocated	9	9
Failure to Power Up	8	8
Improper or Incorrect Procedure or Method	7	7
Unintended Movement	7	7
Failure to Advance	7	7
Biocompatibility	6	6
Migration or Expulsion of Device	6	6
Material Fragmentation	6	6
Material Frayed	4	4
Positioning Failure	4	4
No Apparent Adverse Event	3	3
Difficult to Advance	3	3
Inadequacy of Device Shape and/or Size	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Off-Label Use	3	3
Tear, Rip or Hole in Device Packaging	2	2
Premature Activation	2	2
Electrical /Electronic Property Problem	2	2
Material Separation	2	2
Failure to Osseointegrate	2	2
Difficult to Insert	2	2
Failure to Cut	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Product Quality Problem	2	2
Packaging Problem	2	2
Connection Problem	2	2
Separation Failure	2	2
Difficult to Remove	2	2
Material Integrity Problem	2	2
Material Disintegration	2	2
Device Appears to Trigger Rejection	2	2
Patient-Device Incompatibility	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	273	274
Insufficient Information	183	183
Failure of Implant	109	109
Unspecified Infection	92	92
Implant Pain	64	64
No Consequences Or Impact To Patient	59	59
Nonunion/Delayed-union Bone Fracture	51	51
Pain	47	47
Swelling/ Edema	46	46
No Code Available	45	45
Injury	44	44
Post Operative Wound Infection	40	43
Foreign Body In Patient	37	38
No Known Impact Or Consequence To Patient	35	35
Not Applicable	25	25
Tissue Damage	24	24
Discomfort	22	22
Bone Fracture(s)	19	19
No Patient Involvement	15	15
Cellulitis	14	14
Device Embedded In Tissue or Plaque	13	13
Loss of Range of Motion	12	12
Unspecified Tissue Injury	12	12
Inflammation	11	11
Hypersensitivity/Allergic reaction	10	10
Impaired Healing	10	10
Bacterial Infection	9	9
Swelling	9	9
Physical Asymmetry	8	8
Malunion of Bone	8	8
Deformity/ Disfigurement	7	7
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	6	6
Nerve Damage	6	6
Skin Inflammation/ Irritation	6	6
Organ Dehiscence	5	5
Osteolysis	5	5
Unspecified Musculoskeletal problem	5	5
Joint Disorder	5	5
No Information	5	7
Foreign Body Reaction	4	4
Fall	4	4
Patient Problem/Medical Problem	4	4
Arthritis	3	3
Fracture, Arm	3	3
Tissue Irritation	3	3
Necrosis	3	3
Arthralgia	3	3
Neuropathy	3	3
Sepsis	2	2
Hypoesthesia	2	2