TPLC - Total Product Life Cycle

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Device	instrument, manual, surgical, general use
Product Code	MDM
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	824	824
Adverse Event Without Identified Device or Use Problem	50	50
Entrapment of Device	49	49
Physical Resistance/Sticking	49	49
Difficult to Remove	48	48
Material Twisted/Bent	43	43
Fracture	38	38
Detachment of Device or Device Component	38	38
Dull, Blunt	30	30
Material Fragmentation	30	30
Corroded	19	19
Defective Device	19	19
Mechanical Jam	18	18
Appropriate Term/Code Not Available	16	16
Material Separation	16	16
Component Missing	11	11
Flaked	11	11
Fitting Problem	10	10
Mechanical Problem	10	10
Material Split, Cut or Torn	9	9
Connection Problem	9	9
Material Deformation	9	9
Device Damaged by Another Device	8	8
Failure to Disinfect	8	8
Activation, Positioning or Separation Problem	7	7
Naturally Worn	7	7
Failure to Cut	6	6
Crack	6	6
Use of Device Problem	6	6
Difficult to Open or Close	6	6
Failure to Advance	6	6
Device Difficult to Maintain	5	5
Patient Device Interaction Problem	5	5
Insufficient Information	5	5
Contamination /Decontamination Problem	5	5
Device Dislodged or Dislocated	4	4
Output Problem	4	4
Device-Device Incompatibility	4	4
Device Slipped	4	4
Inadequacy of Device Shape and/or Size	3	3
Unintended Movement	3	3
Difficult to Insert	3	3
Misfire	3	3
Device Damaged Prior to Use	3	3
Delivered as Unsterile Product	3	3
Separation Problem	3	3
Device Contamination with Chemical or Other Material	2	2
Product Quality Problem	2	2
Melted	2	2
Incorrect Measurement	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	642	642
Insufficient Information	256	256
Foreign Body In Patient	191	191
Device Embedded In Tissue or Plaque	83	83
No Known Impact Or Consequence To Patient	66	66
No Consequences Or Impact To Patient	41	41
No Patient Involvement	31	31
Failure of Implant	19	19
Injury	19	19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
Unspecified Infection	9	9
Bone Fracture(s)	9	9
Pain	9	9
No Information	7	7
Unspecified Tissue Injury	6	6
Perforation	6	6
No Code Available	5	5
Low Blood Pressure/ Hypotension	4	4
Pericardial Effusion	4	4
Tissue Damage	3	3
Swelling/ Edema	3	3
Post Operative Wound Infection	3	3
Cardiac Tamponade	3	3
Internal Organ Perforation	2	2
Heart Block	2	2
Joint Laxity	2	2
Discomfort	2	2
Purulent Discharge	2	2
Inflammation	2	2
Metal Related Pathology	2	2
Not Applicable	2	2
Obstruction/Occlusion	1	1
Edema	1	1
Loss of Range of Motion	1	1
Hematoma	1	1
Muscular Rigidity	1	1
Exposure to Body Fluids	1	1
Cardiogenic Shock	1	1
Synovitis	1	1
Increased Appetite	1	1
Laceration(s)	1	1
Subluxation	1	1
Sepsis	1	1
Perforation of Vessels	1	1
Ulcer	1	1
Joint Dislocation	1	1
Hip Fracture	1	1
Pressure Sores	1	1
Bacterial Infection	1	1
Hemorrhage/Bleeding	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Applied Medical Resources Corp	II	Mar-27-2024
2	Arthrex, Inc.	II	Dec-08-2022
3	ENDO Pharmaceuticals Solutions, Inc.	II	Dec-30-2022
4	FlexDex Inc.	II	Jan-27-2022
5	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-29-2024
6	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-06-2023
7	Sklar Instruments	II	Jan-16-2025
8	Technicality Inc.	II	Apr-02-2024