TPLC - Total Product Life Cycle

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Device	blade, saw, general & plastic surgery, surgical
Product Code	GFA
Regulation Number	878.4820
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	753	870
Break	363	363
Material Fragmentation	251	251
Mechanical Jam	171	171
Complete Loss of Power	122	122
Delivered as Unsterile Product	61	72
Smoking	49	49
Dull, Blunt	33	33
Failure to Cut	26	26
Excessive Heating	25	25
Tear, Rip or Hole in Device Packaging	24	24
Overheating of Device	22	22
Device Contaminated During Manufacture or Shipping	20	20
Appropriate Term/Code Not Available	19	19
Detachment of Device or Device Component	19	19
Packaging Problem	13	13
Entrapment of Device	13	13
Defective Device	13	13
Contamination /Decontamination Problem	12	12
Material Integrity Problem	12	12
Separation Problem	11	11
Material Separation	10	10
Material Twisted/Bent	9	9
Contamination	8	8
Physical Resistance/Sticking	8	8
No Apparent Adverse Event	7	7
Insufficient Information	7	7
Insufficient Cooling	7	7
Device-Device Incompatibility	7	7
Material Disintegration	6	7
Adverse Event Without Identified Device or Use Problem	6	6
Loose or Intermittent Connection	6	6
Material Deformation	6	6
Use of Device Problem	6	6
Device Contamination with Chemical or Other Material	5	5
Output Problem	5	5
Continuous Firing	5	5
Fitting Problem	5	5
Activation Failure	4	4
Patient Device Interaction Problem	4	4
Device Slipped	4	4
Unintended Ejection	3	3
Expiration Date Error	3	3
Nonstandard Device	3	3
Premature Separation	3	3
Improper or Incorrect Procedure or Method	3	3
Mechanical Problem	3	3
Temperature Problem	3	3
Missing Information	2	2
Failure to Advance	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1632	1761
Insufficient Information	198	209
No Consequences Or Impact To Patient	102	102
Foreign Body In Patient	83	83
No Patient Involvement	41	41
No Known Impact Or Consequence To Patient	36	36
Device Embedded In Tissue or Plaque	13	21
Burn(s)	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Laceration(s)	6	6
Superficial (First Degree) Burn	5	5
Pain	5	5
Unspecified Tissue Injury	4	4
Unspecified Infection	3	3
No Code Available	3	3
No Information	3	3
Bone Fracture(s)	3	3
Hemorrhage/Bleeding	3	3
Burn, Thermal	2	2
Hypersensitivity/Allergic reaction	1	1
Failure of Implant	1	1
Injury	1	1
Discomfort	1	1
Muscle/Tendon Damage	1	1
Hypoxia	1	1
Myocardial Infarction	1	1
Tissue Breakdown	1	1
Full thickness (Third Degree) Burn	1	1
Hypovolemia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	MEDLINE INDUSTRIES, LP - Northfield	II	Jan-11-2023
2	Synvasive Technology Inc	II	Apr-06-2020