TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	264	264
Material Deformation	170	170
Adverse Event Without Identified Device or Use Problem	117	117
Device-Device Incompatibility	95	95
Entrapment of Device	75	75
Material Fragmentation	48	48
No Apparent Adverse Event	17	17
Device Operates Differently Than Expected	13	13
Material Twisted/Bent	8	8
Mechanical Jam	7	7
Bent	6	6
Difficult to Remove	6	6
Appropriate Term/Code Not Available	6	6
Migration	6	6
Device Slipped	5	5
Migration or Expulsion of Device	4	4
Contamination /Decontamination Problem	4	4
Material Integrity Problem	4	4
Device Handling Problem	4	4
Scratched Material	4	4
Defective Device	3	3
Sticking	3	3
Overheating of Device	2	2
Improper or Incorrect Procedure or Method	2	2
Tear, Rip or Hole in Device Packaging	2	2
Difficult to Advance	2	2
Packaging Problem	2	2
Insufficient Information	2	2
Unintended Movement	1	1
Device Difficult to Maintain	1	1
Device Dislodged or Dislocated	1	1
Material Protrusion/Extrusion	1	1
Failure to Align	1	1
Failure to Cut	1	1
Biocompatibility	1	1
Deformation Due to Compressive Stress	1	1
Activation, Positioning or Separation Problem	1	1
Fitting Problem	1	1
Peeled/Delaminated	1	1
Use of Device Problem	1	1
Metal Shedding Debris	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1
Device Expiration Issue	1	1
Fracture	1	1
Detachment Of Device Component	1	1
Crack	1	1
Disconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	254	254
Foreign Body In Patient	87	87
No Code Available	87	87
No Consequences Or Impact To Patient	76	76
No Known Impact Or Consequence To Patient	68	68
Device Embedded In Tissue or Plaque	38	38
Pain	37	37
No Patient Involvement	35	35
Non-union Bone Fracture	29	29
Unspecified Infection	27	27
Post Operative Wound Infection	19	19
Insufficient Information	19	19
Failure of Implant	15	15
Injury	14	14
Unspecified Tissue Injury	11	11
Sedation	8	8
Nerve Damage	8	8
Bone Fracture(s)	8	8
Hypersensitivity/Allergic reaction	6	6
Necrosis	5	5
Inflammation	5	5
Impaired Healing	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Foreign Body Reaction	4	4
Discomfort	3	3
No Information	3	3
Malunion of Bone	2	2
Needle Stick/Puncture	2	2
Ambulation Difficulties	2	2
Limited Mobility Of The Implanted Joint	2	2
Not Applicable	2	2
Skin Inflammation/ Irritation	2	2
Swelling	2	2
Tissue Damage	2	2
Rupture	2	2
Ulcer	2	2
Bacterial Infection	2	2
Burn(s)	2	2
Cellulitis	1	1
Cerebrospinal Fluid Leakage	1	1
Erythema	1	1
Eye Injury	1	1
Hemorrhage/Bleeding	1	1
Vessel Or Plaque, Device Embedded In	1	1
Abscess	1	1
Arthritis	1	1
Infiltration into Tissue	1	1
Irritation	1	1
Pressure Sores	1	1
Paralysis	1	1
Pneumothorax	1	1
Sepsis	1	1
Joint Dislocation	1	1
Patient Problem/Medical Problem	1	1
Metal Related Pathology	1	1
Physical Asymmetry	1	1
Swelling/ Edema	1	1
Joint Laxity	1	1

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