TPLC - Total Product Life Cycle

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Device	appliance, fixation, spinal interlaminal
Regulation Description	Spinal interlaminal fixation orthosis.
Product Code	KWP
Regulation Number	888.3050
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	780	780
Adverse Event Without Identified Device or Use Problem	307	307
Device Slipped	264	264
Loosening of Implant Not Related to Bone-Ingrowth	187	187
Material Deformation	165	165
Migration	157	157
Device Dislodged or Dislocated	142	142
Fracture	123	123
Mechanics Altered	52	52
Detachment of Device or Device Component	50	50
Device Appears to Trigger Rejection	46	46
Migration or Expulsion of Device	44	44
Device-Device Incompatibility	38	38
Mechanical Problem	38	38
Material Twisted/Bent	35	35
Mechanical Jam	30	30
No Apparent Adverse Event	29	29
Loose or Intermittent Connection	25	25
Malposition of Device	23	23
Failure to Align	22	22
Material Integrity Problem	21	21
Use of Device Problem	20	20
Device Damaged by Another Device	17	17
Unstable	14	14
Patient-Device Incompatibility	12	12
Appropriate Term/Code Not Available	10	10
Failure to Osseointegrate	10	10
Entrapment of Device	9	9
Packaging Problem	9	9
Material Separation	9	9
Expulsion	8	8
Patient Device Interaction Problem	8	8
Compatibility Problem	8	8
Crack	8	8
Degraded	7	7
Insufficient Information	7	7
Product Quality Problem	7	7
Manufacturing, Packaging or Shipping Problem	6	6
Scratched Material	6	6
Difficult to Advance	5	5
Biocompatibility	4	4
Material Fragmentation	4	4
Unintended Movement	4	4
Osseointegration Problem	3	3
Activation, Positioning or Separation Problem	3	3
Corroded	3	3
Difficult to Insert	3	3
Failure to Advance	3	3
Material Erosion	3	3
Inadequacy of Device Shape and/or Size	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1135	1135
Pain	369	369
No Known Impact Or Consequence To Patient	291	291
Failure of Implant	159	159
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	78	78
Insufficient Information	71	71
Seroma	68	68
Implant Pain	66	66
Device Embedded In Tissue or Plaque	61	61
Unspecified Infection	58	58
Bone Fracture(s)	55	55
No Code Available	55	55
No Patient Involvement	38	38
Post Operative Wound Infection	35	35
Injury	35	35
Non-union Bone Fracture	35	35
Foreign Body In Patient	34	34
Ambulation Difficulties	25	25
Stenosis	23	23
Inadequate Osseointegration	23	23
Numbness	23	23
Spinal Column Injury	19	19
No Consequences Or Impact To Patient	19	19
Paralysis	18	18
Nerve Damage	18	18
Spinal Cord Injury	18	18
Patient Problem/Medical Problem	18	18
Neck Pain	16	16
Neurological Deficit/Dysfunction	16	16
Unspecified Nervous System Problem	15	15
Discomfort	14	14
Fall	12	12
Unspecified Tissue Injury	12	12
Osteolysis	11	11
Cerebrospinal Fluid Leakage	11	11
Joint Laxity	10	10
Hematoma	10	10
Headache	10	10
Hemorrhage/Bleeding	10	10
Neuropathy	10	10
Loss of Range of Motion	9	9
Disability	9	9
Unspecified Mental, Emotional or Behavioural Problem	8	8
Burning Sensation	8	8
Weakness	8	8
Impaired Healing	8	8
Foreign Body Reaction	8	8
Arthritis	7	7
Purulent Discharge	7	7
Inflammation	7	7

Recalls
Manufacturer		Recall Class	Date Posted
1	K2M, Inc	II	Mar-01-2022
2	K2M, Inc.	II	Jun-30-2022
3	Medicrea International	II	Mar-11-2020
4	Medicrea International	II	Jan-24-2020
5	Medtronic Sofamor Danek USA Inc	II	Apr-19-2023
6	Medtronic Sofamor Danek USA Inc	II	May-08-2020
7	ulrich medical USA Inc	II	Mar-02-2020