TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	4609	4609
Failure to Cut	1014	1014
Entrapment of Device	737	737
Material Deformation	612	612
Device-Device Incompatibility	604	604
Fracture	565	565
Material Twisted/Bent	341	341
Naturally Worn	249	249
Dull, Blunt	199	199
Mechanical Jam	95	95
Material Integrity Problem	83	83
Contamination /Decontamination Problem	64	64
Physical Resistance/Sticking	56	56
Adverse Event Without Identified Device or Use Problem	49	49
No Apparent Adverse Event	46	46
Material Fragmentation	44	44
Illegible Information	37	37
Detachment of Device or Device Component	36	36
Appropriate Term/Code Not Available	32	32
Degraded	28	28
Corroded	28	28
Scratched Material	20	20
Difficult to Remove	19	19
Use of Device Problem	18	18
Improper or Incorrect Procedure or Method	18	18
Material Separation	15	15
Crack	15	15
Component Missing	15	15
Device Contaminated During Manufacture or Shipping	15	15
Unintended Movement	14	14
Protective Measures Problem	14	14
Overheating of Device	13	13
Packaging Problem	12	12
Mechanical Problem	11	11
Insufficient Information	10	10
Structural Problem	10	10
Separation Failure	7	7
Manufacturing, Packaging or Shipping Problem	6	6
Difficult to Insert	6	6
Device Contamination with Chemical or Other Material	6	6
Noise, Audible	5	5
Flaked	5	5
Patient Device Interaction Problem	5	5
Difficult to Advance	5	5
Delivered as Unsterile Product	5	5
Material Split, Cut or Torn	4	4
Failure to Align	4	4
Device Dislodged or Dislocated	4	4
Tear, Rip or Hole in Device Packaging	4	4
Device Markings/Labelling Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4788	4788
No Consequences Or Impact To Patient	1443	1443
Foreign Body In Patient	918	918
Insufficient Information	672	672
No Code Available	279	279
Device Embedded In Tissue or Plaque	192	192
No Known Impact Or Consequence To Patient	164	164
Not Applicable	114	114
No Patient Involvement	92	92
Injury	57	57
No Information	40	40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	18	18
Bone Fracture(s)	15	15
Unspecified Tissue Injury	14	14
Failure of Implant	12	12
Burn(s)	8	8
Hemorrhage/Bleeding	7	7
Pain	6	6
Patient Problem/Medical Problem	6	6
Unspecified Infection	6	6
Perforation	3	3
Blood Loss	3	3
Tissue Damage	3	3
Impaired Healing	3	3
Paralysis	2	2
Nerve Damage	2	2
Discomfort	2	2
Hypersensitivity/Allergic reaction	2	2
Perforation of Vessels	2	2
Unspecified Musculoskeletal problem	1	1
Hematoma	1	1
Rupture	1	1
Vascular Dissection	1	1
Foreign Body Reaction	1	1
Spinal Column Injury	1	1
Necrosis	1	1
Sepsis	1	1
Pneumothorax	1	1
Fever	1	1
Chills	1	1
Death	1	1
Loss of Range of Motion	1	1
Swelling	1	1
Osteolysis	1	1
Superficial (First Degree) Burn	1	1
Laceration(s)	1	1
Limb Fracture	1	1
Vessel Or Plaque, Device Embedded In	1	1
Swelling/ Edema	1	1
Bacterial Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	AAP Implantate Ag	III	Dec-22-2019
2	Arthrex, Inc.	II	Mar-26-2021
3	Biomet, Inc.	II	Dec-17-2020
4	Flower Orthopedics Corporation	II	Oct-14-2021
5	NEOSTEO	II	Aug-09-2021
6	Paragon 28, Inc.	II	Sep-17-2021
7	Trilliant Surgical, LLC	II	May-05-2020
8	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Mar-06-2024
9	Zimmer GmbH	II	May-23-2019