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	25	25

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	297	297
Fracture	76	76
Material Twisted/Bent	39	39
Bent	19	19
Material Deformation	15	15
Material Fragmentation	8	8
Entrapment of Device	8	8
Device-Device Incompatibility	4	4
Detachment Of Device Component	4	4
Material Split, Cut or Torn	3	3
Crack	3	3
Material Integrity Problem	3	3
Difficult to Remove	3	3
Contamination /Decontamination Problem	3	3
Mechanical Problem	3	3
Naturally Worn	3	3
Defective Device	2	2
Use of Device Problem	2	2
Component Missing	2	2
Detachment of Device or Device Component	2	2
Illegible Information	2	2
No Apparent Adverse Event	2	2
Device Operates Differently Than Expected	2	2
Device Slipped	1	1
Split	1	1
Material Discolored	1	1
Material Separation	1	1
Incorrect Measurement	1	1
Output below Specifications	1	1
Difficult to Insert	1	1
Physical Resistance/Sticking	1	1
Device Dislodged or Dislocated	1	1
Mechanical Jam	1	1
Improper or Incorrect Procedure or Method	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	130	130
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	7	7
Injury	4	4
Not Applicable	3	3
Failure of Implant	1	1
Perforation	1	1
Local Reaction	1	1
Blood Loss	1	1
Spinal Column Injury	1	1
Unspecified Tissue Injury	1	1
Spinal Cord Injury	1	1
Excessive Tear Production	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