TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	272	272
Material Deformation	172	172
Adverse Event Without Identified Device or Use Problem	125	125
Device-Device Incompatibility	107	107
Entrapment of Device	79	79
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
Migration	6	6
Bent	6	6
Difficult to Remove	6	6
Appropriate Term/Code Not Available	6	6
Device Slipped	5	5
Migration or Expulsion of Device	4	4
Device Handling Problem	4	4
Scratched Material	4	4
Contamination /Decontamination Problem	4	4
Material Integrity Problem	4	4
Defective Device	3	3
Sticking	3	3
Overheating of Device	2	2
Insufficient Information	2	2
Difficult to Advance	2	2
Packaging Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Tear, Rip or Hole in Device Packaging	2	2
Fracture	1	1
Device Dislodged or Dislocated	1	1
Metal Shedding Debris	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Failure to Cut	1	1
Device Expiration Issue	1	1
Unintended Movement	1	1
Crack	1	1
Peeled/Delaminated	1	1
Disconnection	1	1
Fitting Problem	1	1
Activation, Positioning or Separation Problem	1	1
Biocompatibility	1	1
Detachment Of Device Component	1	1
Mechanical Problem	1	1
Failure to Align	1	1
Device Difficult to Maintain	1	1
Use of Device Problem	1	1
Loose or Intermittent Connection	1	1
Material Protrusion/Extrusion	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	267	267
Foreign Body In Patient	91	91
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	38	38
No Patient Involvement	35	35
Non-union Bone Fracture	30	30
Unspecified Infection	29	29
Insufficient Information	25	25
Post Operative Wound Infection	19	19
Failure of Implant	15	15
Unspecified Tissue Injury	14	14
Injury	14	14
Bone Fracture(s)	10	10
Nerve Damage	8	8
Sedation	8	8
Impaired Healing	6	6
Hypersensitivity/Allergic reaction	6	6
Necrosis	5	5
Inflammation	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Foreign Body Reaction	4	4
Discomfort	4	4
No Information	3	3
Skin Inflammation/ Irritation	3	3
Wound Dehiscence	3	3
Swelling/ Edema	3	3
Rupture	2	2
Ambulation Difficulties	2	2
Not Applicable	2	2
Arthritis	2	2
Burn(s)	2	2
Limited Mobility Of The Implanted Joint	2	2
Needle Stick/Puncture	2	2
Swelling	2	2
Bacterial Infection	2	2
Malunion of Bone	2	2
Ulcer	2	2
Tissue Damage	2	2
Pressure Sores	1	1
Infiltration into Tissue	1	1
Hemorrhage/Bleeding	1	1
Physical Asymmetry	1	1
Cerebrospinal Fluid Leakage	1	1
Joint Laxity	1	1
Vessel Or Plaque, Device Embedded In	1	1
Patient Problem/Medical Problem	1	1
Eye Injury	1	1

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