TPLC - Total Product Life Cycle

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Device	reamer
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HTO
Regulation Number	888.4540
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cut	14141	14152
Naturally Worn	1873	1878
Break	1641	1647
No Apparent Adverse Event	1053	1053
Corroded	1032	1034
Device-Device Incompatibility	718	720
Adverse Event Without Identified Device or Use Problem	437	437
Material Twisted/Bent	353	353
Entrapment of Device	343	344
Material Deformation	312	312
Contamination /Decontamination Problem	144	146
Illegible Information	91	91
Fracture	90	90
Crack	58	58
Degraded	54	54
Mechanical Jam	41	41
Detachment of Device or Device Component	41	42
Device Contaminated During Manufacture or Shipping	39	39
Material Integrity Problem	35	35
Scratched Material	34	34
Unintended Movement	21	21
Improper or Incorrect Procedure or Method	20	20
Material Discolored	15	15
Dull, Blunt	10	10
Inaccurate Information	10	10
Appropriate Term/Code Not Available	9	9
Structural Problem	9	9
Use of Device Problem	9	9
Device Slipped	7	7
Difficult to Insert	5	5
Material Fragmentation	5	5
Difficult to Remove	4	4
Defective Device	3	3
Material Disintegration	3	3
Physical Resistance/Sticking	3	3
Off-Label Use	3	3
Manufacturing, Packaging or Shipping Problem	2	2
Product Quality Problem	2	2
Material Separation	2	2
Insufficient Information	2	2
Difficult to Open or Remove Packaging Material	2	2
Difficult to Open or Close	2	2
Noise, Audible	2	2
Contamination	1	1
Component Missing	1	1
Failure to Clean Adequately	1	1
Defective Component	1	1
Device Handling Problem	1	1
Difficult to Advance	1	1
Incorrect Measurement	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	17611	17627
Insufficient Information	1279	1279
Foreign Body In Patient	350	351
Unspecified Tissue Injury	30	30
Limb Fracture	21	21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Bone Fracture(s)	10	10
Pain	6	6
Hemorrhage/Bleeding	6	6
Unspecified Infection	5	5
Septic Shock	5	5
Failure of Implant	4	5
Shock	4	4
Embolism/Embolus	3	3
Cardiac Arrest	3	3
Post Operative Wound Infection	3	3
Loss of Range of Motion	3	3
Device Embedded In Tissue or Plaque	3	3
Discomfort	2	2
No Patient Involvement	2	2
Fall	2	2
Non-union Bone Fracture	2	3
Swelling/ Edema	2	2
Hematoma	1	1
Multiple Fractures	1	1
Unspecified Nervous System Problem	1	1
Burn(s)	1	1
Nerve Damage	1	1
Laceration(s)	1	1
Hyperextension	1	1
Perforation of Vessels	1	1
Skin Tears	1	1
Deformity/ Disfigurement	1	1
Low Blood Pressure/ Hypotension	1	1