TPLC - Total Product Life Cycle

show TPLC since

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cut	14553	14553
Naturally Worn	1905	1905
Break	1515	1515
Corroded	1037	1037
Device-Device Incompatibility	693	693
No Apparent Adverse Event	530	530
Material Twisted/Bent	503	503
Adverse Event Without Identified Device or Use Problem	444	444
Dull, Blunt	389	389
Entrapment of Device	343	343
Illegible Information	305	305
Material Deformation	163	163
Contamination /Decontamination Problem	159	159
Crack	84	84
Fracture	82	82
Detachment of Device or Device Component	51	51
Mechanical Jam	50	50
Scratched Material	50	50
Degraded	49	49
Device Contaminated During Manufacture or Shipping	33	33
Material Integrity Problem	33	33
Loose or Intermittent Connection	24	24
Unintended Movement	22	22
Improper or Incorrect Procedure or Method	18	18
Component Missing	15	15
Material Discolored	14	14
Appropriate Term/Code Not Available	12	12
Inaccurate Information	10	10
Structural Problem	9	9
Use of Device Problem	9	9
Physical Resistance/Sticking	7	7
Difficult to Insert	4	4
Material Fragmentation	4	4
Defective Device	3	3
Material Disintegration	3	3
Peeled/Delaminated	3	3
Mechanical Problem	3	3
Device Slipped	3	3
Difficult to Remove	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Insufficient Information	2	2
Product Quality Problem	2	2
Material Separation	2	2
Inadequacy of Device Shape and/or Size	2	2
Device Damaged Prior to Use	2	2
Difficult to Open or Remove Packaging Material	2	2
Difficult to Open or Close	2	2
Off-Label Use	2	2
Noise, Audible	2	2
Battery Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	16729	16729
Insufficient Information	1350	1350
No Consequences Or Impact To Patient	959	959
No Code Available	362	362
Foreign Body In Patient	352	352
Not Applicable	42	42
Unspecified Tissue Injury	29	29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Injury	22	22
Limb Fracture	19	19
Bone Fracture(s)	18	18
No Patient Involvement	17	17
No Known Impact Or Consequence To Patient	8	8
Failure of Implant	6	6
Pain	6	6
Unspecified Infection	5	5
Septic Shock	5	5
Loss of Range of Motion	4	4
Shock	4	4
Hemorrhage/Bleeding	4	4
Post Operative Wound Infection	3	3
Device Embedded In Tissue or Plaque	3	3
Discomfort	2	2
Fall	2	2
Non-union Bone Fracture	2	2
Swelling/ Edema	2	2
Hip Fracture	1	1
Hematoma	1	1
Unspecified Nervous System Problem	1	1
Burn(s)	1	1
Nerve Damage	1	1
Laceration(s)	1	1
Hyperextension	1	1
Physical Entrapment	1	1
Perforation of Vessels	1	1
Tissue Damage	1	1
Skin Tears	1	1
Deformity/ Disfigurement	1	1
Low Blood Pressure/ Hypotension	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