TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	311	311
Calibration Problem	237	237
Device-Device Incompatibility	115	115
Fracture	111	111
Mechanical Problem	78	78
Naturally Worn	66	66
Appropriate Term/Code Not Available	50	50
Material Deformation	49	49
Material Twisted/Bent	38	38
Mechanical Jam	34	34
Crack	28	28
Material Integrity Problem	27	27
Device Operates Differently Than Expected	25	25
Component Missing	24	24
Detachment of Device or Device Component	15	15
Bent	14	14
Scratched Material	14	14
Physical Resistance/Sticking	11	11
Unintended Movement	11	11
Corroded	10	10
Disassembly	10	10
Loose or Intermittent Connection	9	9
Failure to Cut	9	9
Output above Specifications	8	8
Failure to Calibrate	7	7
Output Problem	7	7
Material Torqued	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Difficult to Remove	5	5
Use of Device Problem	5	5
Device Inoperable	4	4
Material Fragmentation	3	3
Structural Problem	3	3
Connection Problem	3	3
Entrapment of Device	3	3
Component or Accessory Incompatibility	3	3
Sticking	3	3
Illegible Information	3	3
Detachment Of Device Component	2	2
Output below Specifications	2	2
Separation Failure	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Failure to Disconnect	2	2
Improper or Incorrect Procedure or Method	2	2
Device Issue	2	2
Failure To Adhere Or Bond	2	2
Fitting Problem	2	2
Compatibility Problem	2	2
Insufficient Information	2	2
Unstable	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	517	517
No Consequences Or Impact To Patient	240	240
No Known Impact Or Consequence To Patient	180	180
No Patient Involvement	107	107
No Information	78	78
Insufficient Information	41	41
No Code Available	28	28
Not Applicable	14	14
Foreign Body In Patient	8	8
Injury	7	7
Sedation	7	7
Device Embedded In Tissue or Plaque	4	4
Failure of Implant	3	3
Bone Fracture(s)	2	2
Spinal Column Injury	2	2
Patient Problem/Medical Problem	1	1
Complaint, Ill-Defined	1	1
Tissue Damage	1	1
Vertebral Fracture	1	1