TPLC - Total Product Life Cycle

• Device: osteotome
• Product Code: HWM
• Regulation Number: 878.4800
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	54	54
2020	57	57
2021	73	73
2022	75	75
2023	72	72
2024	13	13

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	162	162
Failure to Cut	65	65
Material Deformation	54	54
Material Twisted/Bent	27	27
Device-Device Incompatibility	18	18
Fracture	18	18
Naturally Worn	17	17
Scratched Material	12	12
Dull, Blunt	12	12
Material Integrity Problem	7	7
Device Slipped	5	5
Crack	4	4
Use of Device Problem	3	3
Mechanical Jam	3	3
Corroded	3	3
Contamination /Decontamination Problem	3	3
Detachment of Device or Device Component	3	3
Unintended Movement	3	3
Illegible Information	3	3
Adverse Event Without Identified Device or Use Problem	2	2
Mechanical Problem	2	2
Peeled/Delaminated	1	1
Material Separation	1	1
Material Fragmentation	1	1
Difficult to Insert	1	1
Entrapment of Device	1	1
Device Reprocessing Problem	1	1
Defective Component	1	1
Component Missing	1	1
Structural Problem	1	1
Deformation Due to Compressive Stress	1	1
No Apparent Adverse Event	1	1
Material Split, Cut or Torn	1	1
Physical Resistance/Sticking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	224	224
No Consequences Or Impact To Patient	82	82
Insufficient Information	16	16
No Patient Involvement	10	10
No Known Impact Or Consequence To Patient	4	4
No Code Available	3	3
Foreign Body In Patient	3	3
Bone Fracture(s)	2	2
Perforation	1	1
Limb Fracture	1	1