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	369	369
Break	193	193
Device-Device Incompatibility	51	51
Migration	40	40
Fracture	36	36
Device Slipped	35	35
Material Integrity Problem	28	28
Appropriate Term/Code Not Available	27	27
Patient Device Interaction Problem	24	24
Compatibility Problem	22	22
Insufficient Information	21	21
No Apparent Adverse Event	20	20
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
Patient-Device Incompatibility	4	4
Material Deformation	4	4
Material Split, Cut or Torn	3	3
Positioning Problem	3	3
Loose or Intermittent Connection	2	2
Device Dislodged or Dislocated	2	2
Material Separation	2	2
Difficult to Remove	2	2
Defective Device	2	2
Unintended Movement	2	2
Component or Accessory Incompatibility	2	2
Fitting Problem	2	2
Failure to Osseointegrate	1	1
Device Damaged by Another Device	1	1
Difficult to Advance	1	1
Solder Joint Fracture	1	1
Calibration Problem	1	1
Separation Failure	1	1
Crack	1	1
Physical Resistance/Sticking	1	1
Inadequacy of Device Shape and/or Size	1	1
Malposition of Device	1	1
Migration or Expulsion of Device	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	215	215
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	110	110
Insufficient Information	108	108
Non-union Bone Fracture	74	74
Pain	72	72
Post Operative Wound Infection	70	70
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
Cerebrospinal Fluid Leakage	29	29
Perforation of Vessels	29	29
Hematoma	29	29
No Consequences Or Impact To Patient	27	27
No Code Available	26	26
No Known Impact Or Consequence To Patient	24	24
Intervertebral Disc Compression or Protrusion	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
Implant Pain	7	7
Neck Pain	7	7
Impaired Healing	7	7
Thromboembolism	6	6
Loss of Range of Motion	6	6
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
Ambulation Difficulties	3	3
Burning Sensation	3	3
Numbness	3	3
Hypersensitivity/Allergic reaction	3	3
Synovitis	2	2
Embolism/Embolus	2	2
Seroma	2	2
Deformity/ Disfigurement	2	2
Muscular Rigidity	2	2
Fatigue	2	2
Unspecified Kidney or Urinary Problem	2	2

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