TPLC - Total Product Life Cycle

• Device: passer, wire, orthopedic
• Product Code: HXI
• Regulation Number: 888.4540
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2016	35	35
2017	7	7
2018	13	13
2019	1	1
2020	5	5
2021	2	2
2022	8	8
2023	12	12
2024	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	24	24
Device Operates Differently Than Expected	22	22
Fracture	6	6
Material Fragmentation	5	5
Appropriate Term/Code Not Available	5	5
Detachment of Device or Device Component	5	5
Device Operational Issue	4	4
Device Slipped	4	4
Difficult to Insert	3	3
Use of Device Problem	3	3
Improper or Incorrect Procedure or Method	2	2
Patient Device Interaction Problem	2	2
Material Deformation	2	2
Mechanical Problem	2	2
Difficult to Remove	1	1
Material Separation	1	1
Device Inoperable	1	1
Detachment Of Device Component	1	1
Degraded	1	1
Insufficient Information	1	1
Difficult to Advance	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Information	16	16
No Known Impact Or Consequence To Patient	15	15
No Consequences Or Impact To Patient	13	13
No Clinical Signs, Symptoms or Conditions	13	13
Foreign Body In Patient	9	9
Device Embedded In Tissue or Plaque	6	6
Insufficient Information	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
No Code Available	3	3
Blister	3	3
No Patient Involvement	3	3
Rash	3	3
Tissue Damage	1	1
Rheumatoid Arthritis	1	1
Hypersensitivity/Allergic reaction	1	1
Inflammation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Integra LifeSciences Corp.	II	Jun-28-2016