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
AIRS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARMIS BIOPHARMA, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	1
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	5
PACIFIC INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	1
RESTOR3D
	SUBSTANTIALLY EQUIVALENT	1
SKELETAL DYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER GMBH
	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	353	356
Break	206	207
Fracture	79	79
Detachment of Device or Device Component	51	51
Material Split, Cut or Torn	23	23
Appropriate Term/Code Not Available	20	20
Material Deformation	19	19
Use of Device Problem	18	18
Patient Device Interaction Problem	18	18
Device-Device Incompatibility	17	17
Defective Device	17	18
Migration	17	17
Mechanical Jam	15	15
Insufficient Information	14	14
Entrapment of Device	10	11
Material Twisted/Bent	9	9
Activation Failure	9	9
Improper or Incorrect Procedure or Method	8	8
Failure to Power Up	7	7
Physical Resistance/Sticking	7	7
Device Dislodged or Dislocated	7	7
Failure to Advance	7	7
Unintended Movement	7	7
Biocompatibility	6	6
Loose or Intermittent Connection	6	6
Material Fragmentation	6	6
Positioning Problem	5	5
Positioning Failure	4	4
Difficult to Remove	4	4
Therapeutic or Diagnostic Output Failure	4	4
Output Problem	4	4
Material Frayed	4	4
No Apparent Adverse Event	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Tear, Rip or Hole in Device Packaging	3	3
Off-Label Use	3	3
Inadequacy of Device Shape and/or Size	3	3
Unstable	3	3
Material Separation	3	3
Product Quality Problem	3	3
Device Slipped	3	3
Material Rupture	3	3
Material Protrusion/Extrusion	2	2
Device Appears to Trigger Rejection	2	2
Connection Problem	2	2
Premature Activation	2	2
Delivered as Unsterile Product	2	2
Failure to Cut	2	2
Failure to Osseointegrate	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	256	257
Insufficient Information	183	183
Failure of Implant	106	106
Implant Pain	64	64
Unspecified Infection	55	55
Non-union Bone Fracture	51	51
Swelling/ Edema	44	44
Post Operative Wound Infection	37	40
Injury	34	34
Foreign Body In Patient	32	33
Pain	26	26
Discomfort	21	21
Bone Fracture(s)	18	18
No Consequences Or Impact To Patient	17	17
No Known Impact Or Consequence To Patient	16	16
No Code Available	13	13
Unspecified Tissue Injury	12	12
Bacterial Infection	9	9
Hypersensitivity/Allergic reaction	8	8
Physical Asymmetry	8	8
Malunion of Bone	8	8
Deformity/ Disfigurement	7	7
Skin Inflammation/ Irritation	6	6
Device Embedded In Tissue or Plaque	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Impaired Healing	6	6
Unspecified Musculoskeletal problem	5	5
Nerve Damage	5	5
Inflammation	4	4
Foreign Body Reaction	4	4
Loss of Range of Motion	4	4
Osteolysis	4	4
No Patient Involvement	4	4
Fall	4	4
Not Applicable	3	3
Necrosis	3	3
Arthralgia	3	3
Fracture, Arm	3	3
Neuropathy	3	3
No Information	2	2
Sepsis	2	2
Perforation	2	2
Erosion	2	2
Local Reaction	2	2
Swelling	2	2
Joint Laxity	2	2
Limb Fracture	2	2
Inadequate Pain Relief	1	1
Joint Contracture	1	1
Paraplegia	1	1