TPLC - Total Product Life Cycle

• Device: driver, prosthesis
• Product Code: HWR
• Regulation Number: 888.4540
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	678	678
2020	738	738
2021	898	898
2022	980	980
2023	1281	1281
2024	615	615

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	2543	2543
Material Twisted/Bent	1360	1360
Device-Device Incompatibility	651	651
Naturally Worn	349	349
Material Deformation	290	290
Crack	208	208
Entrapment of Device	100	100
Fracture	78	78
Mechanical Jam	74	74
Material Integrity Problem	69	69
Mechanical Problem	65	65
Contamination /Decontamination Problem	40	40
Scratched Material	34	34
Physical Resistance/Sticking	28	28
Component Missing	27	27
Unintended Movement	26	26
Adverse Event Without Identified Device or Use Problem	19	19
Appropriate Term/Code Not Available	17	17
Detachment of Device or Device Component	17	17
No Apparent Adverse Event	13	13
Device Slipped	13	13
Structural Problem	12	12
Calibration Problem	11	11
Material Split, Cut or Torn	11	11
Corroded	9	9
Connection Problem	8	8
Failure to Cut	6	6
Use of Device Problem	6	6
Loose or Intermittent Connection	5	5
Material Fragmentation	5	5
Difficult to Remove	5	5
Material Discolored	4	4
Improper or Incorrect Procedure or Method	3	3
Device Contamination with Chemical or Other Material	3	3
Illegible Information	3	3
Device Handling Problem	2	2
Defective Device	2	2
Defective Component	2	2
Difficult to Insert	2	2
Flaked	2	2
Device Reprocessing Problem	1	1
Component Incompatible	1	1
Fitting Problem	1	1
Device Damaged Prior to Use	1	1
Off-Label Use	1	1
Material Separation	1	1
Separation Failure	1	1
Compatibility Problem	1	1
Moisture or Humidity Problem	1	1
Migration	1	1
Insufficient Information	1	1
Device Difficult to Maintain	1	1
Device Fell	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3617	3617
No Consequences Or Impact To Patient	1118	1118
Insufficient Information	272	272
No Code Available	95	95
Foreign Body In Patient	66	66
Not Applicable	63	63
No Patient Involvement	35	35
No Known Impact Or Consequence To Patient	34	34
No Information	12	12
Injury	5	5
Limb Fracture	4	4
Device Embedded In Tissue or Plaque	2	2
Pain	2	2
Bone Fracture(s)	2	2
Failure of Implant	1	1
Nerve Damage	1	1
Neuropathy	1	1
Spinal Cord Injury	1	1
Burn(s)	1	1
Foreign Body Reaction	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1