TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Deformation	175	175
Break	168	168
Device-Device Incompatibility	106	106
Adverse Event Without Identified Device or Use Problem	100	100
Entrapment of Device	81	81
No Apparent Adverse Event	17	17
Migration	9	9
Device Slipped	5	5
Material Twisted/Bent	5	5
Appropriate Term/Code Not Available	5	5
Material Integrity Problem	4	4
Contamination /Decontamination Problem	4	4
Scratched Material	4	4
Device Handling Problem	4	4
Defective Device	3	3
Difficult to Remove	3	3
Improper or Incorrect Procedure or Method	3	3
Tear, Rip or Hole in Device Packaging	2	2
Disconnection	1	1
Activation, Positioning or Separation Problem	1	1
Mechanical Problem	1	1
Migration or Expulsion of Device	1	1
Difficult to Advance	1	1
Unintended Movement	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Fragmentation	1	1
Use of Device Problem	1	1
Device Difficult to Maintain	1	1
Failure to Cut	1	1
Packaging Problem	1	1
Material Protrusion/Extrusion	1	1
Device Dislodged or Dislocated	1	1
Loose or Intermittent Connection	1	1
Deformation Due to Compressive Stress	1	1
Mechanical Jam	1	1
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	273	273
Foreign Body In Patient	87	87
No Consequences Or Impact To Patient	51	51
No Code Available	46	46
Insufficient Information	29	29
Non-union Bone Fracture	26	26
Pain	22	22
Unspecified Infection	20	20
Post Operative Wound Infection	17	17
Unspecified Tissue Injury	17	17
No Patient Involvement	14	14
Injury	12	12
Bone Fracture(s)	9	9
Failure of Implant	7	7
Hypersensitivity/Allergic reaction	6	6
Inflammation	5	5
Necrosis	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
No Known Impact Or Consequence To Patient	4	4
Nerve Damage	3	3
Foreign Body Reaction	3	3
Hemorrhage/Bleeding	3	3
Wound Dehiscence	3	3
Swelling/ Edema	3	3
Skin Inflammation/ Irritation	3	3
Malunion of Bone	2	2
Arthritis	2	2
Needle Stick/Puncture	2	2
Ambulation Difficulties	2	2
Impaired Healing	2	2
Pneumothorax	2	2
Ulcer	2	2
Pressure Sores	1	1
Discomfort	1	1
Sepsis	1	1
Tissue Damage	1	1
Device Embedded In Tissue or Plaque	1	1
Not Applicable	1	1
Cellulitis	1	1
Cerebrospinal Fluid Leakage	1	1
Erythema	1	1
Eye Injury	1	1
Abscess	1	1
Hematoma	1	1
Metal Related Pathology	1	1
Osteopenia/ Osteoporosis	1	1
Joint Laxity	1	1
Physical Asymmetry	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Exactech, Inc.	II	Oct-21-2019