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	956	960
Adverse Event Without Identified Device or Use Problem	480	481
Device Slipped	267	267
Loosening of Implant Not Related to Bone-Ingrowth	239	240
Material Deformation	219	219
Device Dislodged or Dislocated	192	195
Migration	182	182
Fracture	148	148
Detachment of Device or Device Component	84	84
Mechanics Altered	77	78
Mechanical Problem	69	69
Device Appears to Trigger Rejection	47	47
Migration or Expulsion of Device	46	46
Device-Device Incompatibility	42	42
Material Twisted/Bent	42	42
Malposition of Device	39	39
Device Damaged by Another Device	36	37
Mechanical Jam	33	33
No Apparent Adverse Event	33	33
Product Quality Problem	30	30
Failure to Align	28	28
Loose or Intermittent Connection	23	23
Material Integrity Problem	22	22
Use of Device Problem	21	21
Insufficient Device Problem Information	17	19
Unstable	14	15
Patient-Device Incompatibility	13	13
Degraded	11	11
Failure to Osseointegrate	10	10
Packaging Problem	9	9
Material Separation	9	9
Crack	9	9
Entrapment of Device	9	9
Patient Device Interaction Problem	8	8
Osseointegration Problem	8	8
Compatibility Problem	8	8
Expulsion	8	8
Biocompatibility	8	8
Manufacturing, Packaging or Shipping Problem	6	6
Appropriate Device Problem Term/Code Not Available	6	6
Scratched Material	6	6
Material Fragmentation	6	6
Material Discolored	6	6
Difficult to Advance	5	5
Nonstandard Device	4	4
Difficult to Insert	4	4
Defective Device	4	4
Unintended Movement	4	4
Wrong Label	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	1529	1531
Pain	556	574
No Known Impact Or Consequence To Patient	291	291
Bone Fracture(s)	170	170
Failure of Implant	162	167
Numbness	130	141
Unspecified Tissue Injury	108	108
Loss of Range of Motion	107	107
Inflammation	106	106
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	105	105
Impaired Healing	102	102
Fatigue	102	102
Insufficient Information	97	100
Thrombosis/Thrombus	96	96
Depression	95	95
Device Embedded In Tissue or Plaque	75	75
Seroma	68	68
Unspecified Infection	67	68
Implant Pain	66	66
No Code Available	55	55
Post Operative Wound Infection	44	44
Inadequate Osseointegration	42	42
Foreign Body In Patient	41	41
Nonunion/Delayed-union Bone Fracture	39	40
No Patient Involvement	38	38
Injury	35	35
Stenosis	33	33
Ambulation or Postural Difficulties	33	33
Unspecified Nervous System Problem	27	27
Spinal Column Injury	25	25
Paralysis	24	24
Nerve Damage	23	23
Spinal Cord Injury	22	22
Neck Pain	21	21
Back pain	20	20
Neuropathy	20	20
No Consequences Or Impact To Patient	19	19
Discomfort	18	19
Patient Problem/Medical Problem	18	18
Fall	17	17
Neurological Deficit/Dysfunction	16	16
Headache	15	26
Hemorrhage/Blood Loss/Bleeding	13	15
Foreign Body Reaction	13	13
Cerebrospinal Fluid Leakage	12	12
Hypersensitivity/Allergic reaction	12	14
Osteolysis	11	11
Difficulty Chewing	11	11
Dysphasia	11	11
Joint Laxity	10	10

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