TPLC - Total Product Life Cycle

• Device: bone mill
• Product Code: LYS
• Regulation Number: 888.4540
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	2	2
2017	1	1
2018	46	46
2019	54	54
2020	66	66
2021	173	173
2022	201	201
2023	386	386
2024	43	43

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cut	782	782
Dull, Blunt	136	136
Naturally Worn	34	34
Material Deformation	31	31
Break	19	19
Illegible Information	14	14
Device-Device Incompatibility	13	13
Material Twisted/Bent	10	10
Contamination /Decontamination Problem	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Scratched Material	3	3
No Apparent Adverse Event	3	3
Appropriate Term/Code Not Available	3	3
Material Integrity Problem	2	2
Loose or Intermittent Connection	2	2
Mechanical Problem	2	2
Device Abrasion From Instrument Or Another Object	1	1
Use of Device Problem	1	1
Failure to Osseointegrate	1	1
Improper or Incorrect Procedure or Method	1	1
Incorrect Measurement	1	1
Corroded	1	1
Degraded	1	1
Insufficient Information	1	1
Device Operates Differently Than Expected	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	760	760
No Consequences Or Impact To Patient	148	148
Insufficient Information	52	52
No Code Available	12	12
Not Applicable	8	8
No Information	2	2
Missing Value Reason	1	1
Non-union Bone Fracture	1	1
No Known Impact Or Consequence To Patient	1	1
Bone Fracture(s)	1	1
Nerve Damage	1	1