TPLC - Total Product Life Cycle

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

MDR Year	MDR Reports	MDR Events
2014	11	11
2015	33	33
2016	44	44
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	288	288
Fracture	71	71
Material Twisted/Bent	39	39
Bent	19	19
Material Deformation	12	12
Entrapment of Device	8	8
Material Fragmentation	7	7
Detachment Of Device Component	4	4
Device-Device Incompatibility	4	4
Contamination /Decontamination Problem	3	3
Naturally Worn	3	3
Material Split, Cut or Torn	3	3
Crack	3	3
Mechanical Problem	3	3
Difficult to Remove	3	3
Use of Device Problem	2	2
Illegible Information	2	2
Defective Device	2	2
No Apparent Adverse Event	2	2
Detachment of Device or Device Component	2	2
Device Operates Differently Than Expected	2	2
Component Missing	2	2
Material Integrity Problem	2	2
Device Dislodged or Dislocated	1	1
Split	1	1
Output below Specifications	1	1
Physical Resistance/Sticking	1	1
Improper or Incorrect Procedure or Method	1	1
Material Separation	1	1
Device Slipped	1	1
Material Discolored	1	1
Difficult to Insert	1	1
Incorrect Measurement	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	149	149
No Clinical Signs, Symptoms or Conditions	116	116
No Consequences Or Impact To Patient	58	58
Device Embedded In Tissue or Plaque	35	35
Foreign Body In Patient	34	34
No Patient Involvement	27	27
No Information	19	19
No Code Available	8	8
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

Recalls
Manufacturer		Recall Class	Date Posted
1	SpineFrontier, Inc.	II	Jan-03-2014
2	Zimmer Trabecular Metal Technology, Inc.	II	Dec-23-2014