TPLC - Total Product Life Cycle

• Device: trousers, anti-shock
• Product Code: LHX
• Regulation Number: 870.5800
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2014	4	4
2015	8	8
2016	2	2
2017	5	5
2018	10	10
2019	26	26
2020	2	2
2021	5	5
2022	14	14
2023	22	22
2024	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	37	37
Fracture	23	23
Adverse Event Without Identified Device or Use Problem	8	8
Loosening of Implant Not Related to Bone-Ingrowth	8	8
Loose or Intermittent Connection	6	6
Device Damaged Prior to Use	4	4
Component Missing	4	4
Migration or Expulsion of Device	3	3
Insufficient Information	3	3
Appropriate Term/Code Not Available	3	3
Tip breakage	3	3
Material Deformation	2	2
Naturally Worn	2	2
Crack	2	2
Positioning Failure	1	1
Detachment Of Device Component	1	1
Mechanical Problem	1	1
Difficult to Insert	1	1
Difficult to Remove	1	1
Material Separation	1	1
Inadequacy of Device Shape and/or Size	1	1
Failure to Advance	1	1
Patient-Device Incompatibility	1	1
Detachment of Device or Device Component	1	1
Device Dislodged or Dislocated	1	1
Compatibility Problem	1	1
Device Inoperable	1	1
Use of Device Problem	1	1
Scratched Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	38	38
No Clinical Signs, Symptoms or Conditions	23	23
Pain	10	10
No Information	8	8
Foreign Body In Patient	6	6
Failure of Implant	5	5
Loss of Range of Motion	5	5
Bone Fracture(s)	5	5
Rheumatoid Arthritis	4	4
Non-union Bone Fracture	4	4
Joint Dislocation	4	4
No Known Impact Or Consequence To Patient	4	4
Insufficient Information	4	4
Subluxation	4	4
Unequal Limb Length	2	2
No Code Available	2	2
No Patient Involvement	2	2
Foreign body, removal of	2	2
Device Embedded In Tissue or Plaque	1	1
Erosion	1	1
Connective Tissue Disease	1	1
Hemorrhage/Bleeding	1	1
Unknown (for use when the patient's condition is not known)	1	1
Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Stryker Spine	II	Feb-16-2010