TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cut	14604	14604
Naturally Worn	2068	2068
Break	1712	1712
Dull, Blunt	1384	1384
Corroded	1297	1297
Device-Device Incompatibility	747	747
Material Twisted/Bent	699	699
No Apparent Adverse Event	527	527
Adverse Event Without Identified Device or Use Problem	482	482
Entrapment of Device	346	346
Material Deformation	328	328
Illegible Information	299	299
Contamination /Decontamination Problem	172	172
Crack	112	112
Scratched Material	87	87
Fracture	84	84
Detachment of Device or Device Component	62	62
Mechanical Jam	58	58
Device Contamination with Chemical or Other Material	46	46
Degraded	45	45
Material Discolored	40	40
Device Contaminated During Manufacture or Shipping	33	33
Material Integrity Problem	32	32
Loose or Intermittent Connection	24	24
Physical Resistance/Sticking	22	22
Component Missing	21	21
Unintended Movement	21	21
Improper or Incorrect Procedure or Method	18	18
Difficult to Insert	13	13
Appropriate Term/Code Not Available	12	12
Inaccurate Information	10	10
Use of Device Problem	9	9
Structural Problem	9	9
Product Quality Problem	7	7
Peeled/Delaminated	7	7
Difficult to Open or Close	7	7
Material Fragmentation	6	6
Difficult to Remove	5	5
Device Slipped	5	5
Off-Label Use	4	4
Failure to Advance	4	4
Device Damaged Prior to Use	4	4
Mechanical Problem	4	4
Connection Problem	4	4
Failure to Clean Adequately	4	4
Defective Device	3	3
Insufficient Information	3	3
Material Disintegration	3	3
Positioning Failure	3	3
Loss of or Failure to Bond	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	16495	16495
No Consequences Or Impact To Patient	2614	2614
Insufficient Information	1232	1232
No Code Available	405	405
Foreign Body In Patient	357	357
Not Applicable	151	151
No Patient Involvement	81	81
Bone Fracture(s)	48	48
Injury	31	31
No Known Impact Or Consequence To Patient	30	30
Unspecified Tissue Injury	25	25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Unspecified Infection	20	20
Limb Fracture	19	19
Pain	13	13
Non-union Bone Fracture	9	9
Failure of Implant	6	6
Blood Loss	6	6
Device Embedded In Tissue or Plaque	5	5
Septic Shock	5	5
Loss of Range of Motion	4	4
Shock	4	4
No Information	4	4
Hemorrhage/Bleeding	4	4
Discomfort	3	3
Post Operative Wound Infection	3	3
Low Blood Pressure/ Hypotension	3	3
Fall	2	2
Hematoma	2	2
Tissue Damage	2	2
Paresthesia	1	1
Unspecified Nervous System Problem	1	1
Neurological Deficit/Dysfunction	1	1
Foreign Body Reaction	1	1
Burn(s)	1	1
Ossification	1	1
Anemia	1	1
Nerve Damage	1	1
Cyst(s)	1	1
Laceration(s)	1	1
Hyperextension	1	1
Bradycardia	1	1
Physical Entrapment	1	1
Respiratory Distress	1	1
Perforation of Vessels	1	1
Swelling/ Edema	1	1
Embolism	1	1
Skin Tears	1	1
Hip Fracture	1	1
Deformity/ Disfigurement	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Synthes (USA) Products LLC	II	Mar-01-2024
2	Synthes (USA) Products LLC	II	Dec-15-2020
3	T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.	II	Mar-20-2020
4	Zimmer, Inc.	II	Feb-06-2023