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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	345	345
Break	201	201
Fracture	73	73
Detachment of Device or Device Component	51	51
Material Split, Cut or Torn	24	24
Appropriate Term/Code Not Available	20	20
Material Deformation	19	19
Use of Device Problem	18	18
Defective Device	17	17
Migration	16	16
Device-Device Incompatibility	15	15
Mechanical Jam	14	14
Insufficient Information	12	12
Entrapment of Device	10	10
Activation Failure	9	9
Material Twisted/Bent	9	9
Patient Device Interaction Problem	9	9
Improper or Incorrect Procedure or Method	8	8
Device Dislodged or Dislocated	7	7
Failure to Advance	7	7
Physical Resistance/Sticking	7	7
Failure to Power Up	7	7
Unintended Movement	7	7
Loose or Intermittent Connection	6	6
Material Fragmentation	6	6
Positioning Problem	5	5
Difficult to Remove	4	4
Therapeutic or Diagnostic Output Failure	4	4
Material Frayed	4	4
Output Problem	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Device Slipped	3	3
Unstable	3	3
Off-Label Use	3	3
Positioning Failure	3	3
Tear, Rip or Hole in Device Packaging	3	3
Material Separation	3	3
Product Quality Problem	3	3
Material Rupture	3	3
Premature Activation	2	2
Connection Problem	2	2
Migration or Expulsion of Device	2	2
No Apparent Adverse Event	2	2
Material Protrusion/Extrusion	2	2
Inadequacy of Device Shape and/or Size	2	2
Delivered as Unsterile Product	2	2
Failure to Cut	2	2
Failure to Osseointegrate	2	2
Component Missing	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	250	250
Insufficient Information	180	180
Failure of Implant	99	99
Implant Pain	64	64
Unspecified Infection	54	54
Non-union Bone Fracture	51	51
Swelling/ Edema	44	44
Injury	34	34
Post Operative Wound Infection	34	34
Foreign Body In Patient	30	30
Pain	25	25
Discomfort	21	21
No Consequences Or Impact To Patient	17	17
Bone Fracture(s)	17	17
No Known Impact Or Consequence To Patient	16	16
No Code Available	13	13
Unspecified Tissue Injury	11	11
Physical Asymmetry	8	8
Bacterial Infection	6	6
Skin Inflammation/ Irritation	6	6
Deformity/ Disfigurement	6	6
Device Embedded In Tissue or Plaque	6	6
Hypersensitivity/Allergic reaction	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Unspecified Musculoskeletal problem	5	5
Nerve Damage	5	5
Malunion of Bone	5	5
Loss of Range of Motion	4	4
Osteolysis	4	4
No Patient Involvement	4	4
Impaired Healing	4	4
Fall	4	4
Inflammation	3	3
Necrosis	3	3
Not Applicable	3	3
Fracture, Arm	3	3
Neuropathy	3	3
No Information	2	2
Perforation	2	2
Erosion	2	2
Sepsis	2	2
Swelling	2	2
Joint Laxity	2	2
Limb Fracture	2	2
Inadequate Pain Relief	1	1
Joint Contracture	1	1
Pseudoaneurysm	1	1
Paraplegia	1	1
Granuloma	1	1
Ulcer	1	1