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
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	3
PACIFIC INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	1
RESTOR3D
	SUBSTANTIALLY EQUIVALENT	1
SKELETAL DYNAMICS, INC.
	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	241	244
Break	174	175
Fracture	51	51
Detachment of Device or Device Component	50	50
Material Split, Cut or Torn	23	23
Patient Device Interaction Problem	20	20
Material Deformation	19	19
Use of Device Problem	18	18
Migration	17	17
Defective Device	17	18
Appropriate Term/Code Not Available	14	14
Insufficient Information	13	13
Mechanical Jam	11	11
Device-Device Incompatibility	10	10
Activation Failure	9	9
Entrapment of Device	8	9
Improper or Incorrect Procedure or Method	7	7
Unintended Movement	7	7
Device Dislodged or Dislocated	7	7
Failure to Advance	7	7
Failure to Power Up	6	6
Biocompatibility	6	6
Material Twisted/Bent	5	5
Physical Resistance/Sticking	5	5
Loose or Intermittent Connection	5	5
Material Fragmentation	5	5
Output Problem	4	4
Positioning Problem	4	4
Material Frayed	4	4
No Apparent Adverse Event	3	3
Positioning Failure	3	3
Therapeutic or Diagnostic Output Failure	3	3
Off-Label Use	3	3
Product Quality Problem	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Inadequacy of Device Shape and/or Size	3	3
Failure to Cut	2	2
Separation Failure	2	2
Difficult to Advance	2	2
Material Disintegration	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Premature Activation	2	2
Device Appears to Trigger Rejection	2	2
Difficult to Remove	2	2
Tear, Rip or Hole in Device Packaging	2	2
Material Integrity Problem	2	2
Unstable	2	2
Device Slipped	2	2
Material Separation	2	2
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	248	249
Insufficient Information	180	180
Failure of Implant	97	97
Implant Pain	61	61
Swelling/ Edema	46	46
Non-union Bone Fracture	27	27
Foreign Body In Patient	24	25
Pain	22	22
Discomfort	20	20
Bone Fracture(s)	16	16
Post Operative Wound Infection	15	18
Unspecified Infection	13	13
Unspecified Tissue Injury	12	12
Hypersensitivity/Allergic reaction	8	8
Physical Asymmetry	8	8
Malunion of Bone	8	8
Impaired Healing	6	6
Bacterial Infection	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Skin Inflammation/ Irritation	6	6
Loss of Range of Motion	6	6
Deformity/ Disfigurement	5	5
Unspecified Musculoskeletal problem	5	5
Foreign Body Reaction	4	4
Fall	4	4
Nerve Damage	3	3
Inflammation	3	3
Osteolysis	3	3
Arthralgia	3	3
Neuropathy	3	3
Device Embedded In Tissue or Plaque	3	3
Local Reaction	2	2
Perforation	2	2
Limb Fracture	2	2
Sepsis	2	2
Joint Laxity	2	2
Paresthesia	1	1
Purulent Discharge	1	1
Needle Stick/Puncture	1	1
Hematoma	1	1
Erythema	1	1
Muscular Rigidity	1	1
Urinary Retention	1	1
Necrosis	1	1
Laceration(s)	1	1
Muscle/Tendon Damage	1	1
Inadequate Osseointegration	1	1
Joint Contracture	1	1
Drug Resistant Bacterial Infection	1	1
Pseudoaneurysm	1	1