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	181	182
Fracture	52	52
Detachment of Device or Device Component	50	50
Material Split, Cut or Torn	23	23
Patient Device Interaction Problem	21	21
Material Deformation	20	20
Use of Device Problem	20	20
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
Failure to Advance	7	7
Device Dislodged or Dislocated	7	7
Unintended Movement	7	7
Biocompatibility	6	6
Failure to Power Up	6	6
Material Twisted/Bent	5	5
Material Fragmentation	5	5
Physical Resistance/Sticking	5	5
Loose or Intermittent Connection	5	5
Positioning Problem	4	4
Positioning Failure	4	4
Output Problem	4	4
Material Frayed	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Difficult to Advance	3	3
Off-Label Use	3	3
Product Quality Problem	3	3
Inadequacy of Device Shape and/or Size	3	3
No Apparent Adverse Event	3	3
Material Integrity Problem	2	2
Device Appears to Trigger Rejection	2	2
Difficult to Remove	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Separation Failure	2	2
Material Disintegration	2	2
Failure to Cut	2	2
Premature Activation	2	2
Unstable	2	2
Device Slipped	2	2
Material Separation	2	2
Tear, Rip or Hole in Device Packaging	2	2
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	259	260
Insufficient Information	180	180
Failure of Implant	98	98
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	9	9
Physical Asymmetry	8	8
Malunion of Bone	8	8
Impaired Healing	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Bacterial Infection	6	6
Skin Inflammation/ Irritation	6	6
Loss of Range of Motion	6	6
Deformity/ Disfigurement	5	5
Unspecified Musculoskeletal problem	5	5
Fall	4	4
Foreign Body Reaction	4	4
Device Embedded In Tissue or Plaque	3	3
Osteolysis	3	3
Nerve Damage	3	3
Inflammation	3	3
Arthralgia	3	3
Neuropathy	3	3
Local Reaction	2	2
Perforation	2	2
Limb Fracture	2	2
Joint Laxity	2	2
Sepsis	2	2
Muscular Rigidity	1	1
Erythema	1	1
Needle Stick/Puncture	1	1
Urinary Retention	1	1
Paresthesia	1	1
Purulent Discharge	1	1
Laceration(s)	1	1
Hematoma	1	1
Muscle/Tendon Damage	1	1
Necrosis	1	1
Inadequate Osseointegration	1	1
Pseudoaneurysm	1	1
Joint Contracture	1	1
Drug Resistant Bacterial Infection	1	1