TPLC - Total Product Life Cycle

• Device: probe
• Product Code: HXB
• Regulation Number: 888.4540
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2017	58	58
2018	63	63
2019	69	69
2020	39	39
2021	35	35
2022	41	41
2023	47	47
2024	8	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	221	221
Fracture	60	60
Material Twisted/Bent	37	37
Bent	17	17
Material Deformation	12	12
Entrapment of Device	8	8
Material Fragmentation	6	6
Device-Device Incompatibility	4	4
Contamination /Decontamination Problem	3	3
Material Split, Cut or Torn	3	3
No Apparent Adverse Event	2	2
Illegible Information	2	2
Detachment of Device or Device Component	2	2
Material Integrity Problem	2	2
Detachment Of Device Component	2	2
Mechanical Problem	2	2
Use of Device Problem	2	2
Component Missing	2	2
Split	1	1
Defective Device	1	1
Difficult to Remove	1	1
Material Separation	1	1
Device Slipped	1	1
Material Discolored	1	1
Difficult to Insert	1	1
Incorrect Measurement	1	1
Naturally Worn	1	1
Device Dislodged or Dislocated	1	1
Physical Resistance/Sticking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	116	116
No Known Impact Or Consequence To Patient	104	104
No Consequences Or Impact To Patient	49	49
Foreign Body In Patient	31	31
No Patient Involvement	22	22
Device Embedded In Tissue or Plaque	16	16
No Information	11	11
No Code Available	7	7
Insufficient Information	4	4
Injury	4	4
Not Applicable	3	3
Unspecified Tissue Injury	1	1
Spinal Cord Injury	1	1
Blood Loss	1	1
Excessive Tear Production	1	1
Failure of Implant	1	1
Perforation	1	1
Local Reaction	1	1
Spinal Column Injury	1	1