TPLC - Total Product Life Cycle

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Device	orthosis, spinal pedicle fixation
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	372	372
Break	187	187
Device-Device Incompatibility	51	51
Migration	38	38
Device Slipped	31	31
Appropriate Term/Code Not Available	31	31
Fracture	29	29
Material Integrity Problem	28	28
Patient Device Interaction Problem	24	24
Insufficient Information	21	21
No Apparent Adverse Event	20	20
Compatibility Problem	18	18
Entrapment of Device	16	16
Detachment of Device or Device Component	14	14
Material Twisted/Bent	11	11
Mechanical Problem	8	8
Loosening of Implant Not Related to Bone-Ingrowth	6	6
Material Fragmentation	5	5
Material Deformation	4	4
Patient-Device Incompatibility	4	4
Positioning Problem	3	3
Material Split, Cut or Torn	3	3
Difficult to Remove	2	2
Defective Device	2	2
Unintended Movement	2	2
Material Separation	2	2
Component or Accessory Incompatibility	2	2
Device Dislodged or Dislocated	2	2
Fitting Problem	2	2
Loose or Intermittent Connection	2	2
Difficult to Advance	1	1
Separation Failure	1	1
Crack	1	1
Device Damaged by Another Device	1	1
Physical Resistance/Sticking	1	1
Solder Joint Fracture	1	1
Calibration Problem	1	1
Malposition of Device	1	1
Migration or Expulsion of Device	1	1
Inadequacy of Device Shape and/or Size	1	1
Device Appears to Trigger Rejection	1	1
Improper or Incorrect Procedure or Method	1	1
Deformation Due to Compressive Stress	1	1
Mechanical Jam	1	1
Loss of or Failure to Bond	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	203	203
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	112	112
Insufficient Information	104	104
Non-union Bone Fracture	72	72
Post Operative Wound Infection	70	70
Pain	68	68
Nerve Damage	60	60
Failure of Implant	55	55
Unspecified Tissue Injury	53	53
Osteolysis	45	45
Unspecified Infection	43	43
Bone Fracture(s)	34	34
Joint Laxity	31	31
Hematoma	31	31
Cerebrospinal Fluid Leakage	29	29
Perforation of Vessels	29	29
No Consequences Or Impact To Patient	27	27
No Code Available	26	26
Intervertebral Disc Compression or Protrusion	24	24
No Known Impact Or Consequence To Patient	24	24
Physical Asymmetry	22	22
Decreased Sensitivity	20	20
Vertebral Fracture	17	17
Foreign Body In Patient	16	16
Spinal Cord Injury	15	15
Neuralgia	10	10
Malunion of Bone	9	9
Neck Pain	7	7
Impaired Healing	7	7
Implant Pain	7	7
Loss of Range of Motion	6	6
Thromboembolism	6	6
Unspecified Nervous System Problem	5	5
Injury	5	5
Thrombosis/Thrombus	5	5
Necrosis	5	5
Discomfort	5	5
Hemorrhage/Bleeding	5	5
Device Embedded In Tissue or Plaque	3	3
Ambulation Difficulties	3	3
Hypersensitivity/Allergic reaction	3	3
Seroma	2	2
Burning Sensation	2	2
Muscular Rigidity	2	2
Numbness	2	2
Fatigue	2	2
Unspecified Kidney or Urinary Problem	2	2
Deformity/ Disfigurement	2	2
Synovitis	2	2
Stenosis	2	2

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