TPLC - Total Product Life Cycle

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Device	orthosis, spinal pedicle fixation
Regulation Description	Thoracolumbosacral pedicle screw system.
Product Code	MNI
Regulation Number	888.3070
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	386	393
Break	196	199
Device-Device Incompatibility	52	53
Fracture	45	47
Migration	40	40
Device Slipped	35	40
Appropriate Term/Code Not Available	27	27
Material Integrity Problem	27	27
Compatibility Problem	24	24
Patient Device Interaction Problem	24	24
Insufficient Information	22	22
No Apparent Adverse Event	20	20
Entrapment of Device	16	16
Detachment of Device or Device Component	14	15
Patient-Device Incompatibility	14	14
Material Twisted/Bent	11	11
Mechanical Problem	8	9
Loosening of Implant Not Related to Bone-Ingrowth	7	7
Material Fragmentation	5	5
Material Deformation	4	4
Material Separation	3	3
Positioning Problem	3	3
Material Split, Cut or Torn	3	3
Difficult to Remove	2	2
Defective Device	2	2
Unintended Movement	2	2
Device Dislodged or Dislocated	2	2
Component or Accessory Incompatibility	2	2
Fitting Problem	2	2
Loose or Intermittent Connection	2	2
Difficult to Advance	1	1
Separation Failure	1	1
Device Damaged by Another Device	1	1
Failure to Osseointegrate	1	1
Solder Joint Fracture	1	1
Crack	1	1
Calibration Problem	1	1
Physical Resistance/Sticking	1	1
Migration or Expulsion of Device	1	1
Malposition of Device	1	1
Inadequacy of Device Shape and/or Size	1	1
Device Appears to Trigger Rejection	1	1
Deformation Due to Compressive Stress	1	1
Mechanical Jam	1	1
Improper or Incorrect Procedure or Method	1	1
Noise, Audible	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	227	229
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	112	112
Insufficient Information	110	115
Pain	79	83
Failure of Implant	75	78
Non-union Bone Fracture	74	74
Post Operative Wound Infection	70	71
Nerve Damage	60	60
Unspecified Tissue Injury	53	53
Osteolysis	45	45
Unspecified Infection	44	44
Bone Fracture(s)	35	35
Joint Laxity	33	33
Cerebrospinal Fluid Leakage	29	29
Perforation of Vessels	29	29
Hematoma	29	29
No Consequences Or Impact To Patient	27	27
Intervertebral Disc Compression or Protrusion	26	26
No Code Available	26	26
No Known Impact Or Consequence To Patient	24	24
Physical Asymmetry	22	28
Decreased Sensitivity	20	20
Vertebral Fracture	17	17
Spinal Cord Injury	17	17
Foreign Body In Patient	16	16
Neuralgia	10	10
Malunion of Bone	9	9
Neck Pain	8	8
Stenosis	8	8
Implant Pain	7	9
Impaired Healing	7	8
Thromboembolism	6	6
Loss of Range of Motion	6	6
Ambulation Difficulties	5	5
Necrosis	5	5
Unspecified Nervous System Problem	5	5
Injury	5	5
Thrombosis/Thrombus	5	5
Hemorrhage/Bleeding	5	5
Discomfort	5	5
Device Embedded In Tissue or Plaque	3	3
Burning Sensation	3	3
Numbness	3	3
Hypersensitivity/Allergic reaction	3	3
Synovitis	2	3
Embolism/Embolus	2	2
Deformity/ Disfigurement	2	2
Seroma	2	2
Muscular Rigidity	2	2
Wound Dehiscence	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Medicrea International	II	Aug-24-2023