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	887	891
Adverse Event Without Identified Device or Use Problem	325	336
Device Slipped	266	266
Loosening of Implant Not Related to Bone-Ingrowth	198	198
Material Deformation	181	181
Device Dislodged or Dislocated	166	166
Migration	164	164
Fracture	131	131
Mechanics Altered	68	68
Detachment of Device or Device Component	55	55
Device Appears to Trigger Rejection	46	46
Migration or Expulsion of Device	45	45
Mechanical Problem	44	44
Material Twisted/Bent	41	41
Device-Device Incompatibility	39	39
Mechanical Jam	32	32
No Apparent Adverse Event	30	30
Failure to Align	25	25
Loose or Intermittent Connection	25	25
Malposition of Device	24	24
Use of Device Problem	21	21
Material Integrity Problem	21	21
Device Damaged by Another Device	19	19
Patient-Device Incompatibility	14	16
Unstable	14	14
Insufficient Information	13	13
Product Quality Problem	12	12
Appropriate Term/Code Not Available	11	11
Degraded	11	11
Entrapment of Device	10	10
Failure to Osseointegrate	10	10
Material Separation	9	9
Packaging Problem	9	9
Crack	9	9
Patient Device Interaction Problem	8	8
Compatibility Problem	8	8
Expulsion	8	8
Biocompatibility	8	8
Manufacturing, Packaging or Shipping Problem	6	6
Scratched Material	6	6
Material Fragmentation	6	6
Difficult to Advance	5	5
Unintended Movement	4	4
Defective Device	4	4
Corroded	4	4
Failure to Advance	3	3
Nonstandard Device	3	3
Inadequacy of Device Shape and/or Size	3	3
Osseointegration Problem	3	3
Difficult to Insert	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1307	1307
Pain	392	406
No Known Impact Or Consequence To Patient	291	291
Failure of Implant	161	166
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	87	87
Insufficient Information	82	83
Device Embedded In Tissue or Plaque	72	72
Seroma	68	68
Implant Pain	64	64
Unspecified Infection	60	60
Bone Fracture(s)	57	57
No Code Available	55	55
Foreign Body In Patient	40	40
No Patient Involvement	38	38
Non-union Bone Fracture	37	37
Post Operative Wound Infection	36	36
Injury	35	35
Numbness	29	40
Inadequate Osseointegration	28	28
Ambulation Difficulties	25	25
Stenosis	24	24
Spinal Column Injury	22	22
Spinal Cord Injury	19	19
No Consequences Or Impact To Patient	19	19
Nerve Damage	18	18
Paralysis	18	18
Patient Problem/Medical Problem	18	18
Discomfort	17	17
Unspecified Nervous System Problem	17	17
Neck Pain	16	16
Neurological Deficit/Dysfunction	16	16
Neuropathy	15	15
Inflammation	13	13
Foreign Body Reaction	13	13
Unspecified Tissue Injury	12	12
Fall	12	12
Cerebrospinal Fluid Leakage	12	12
Osteolysis	11	11
Hemorrhage/Bleeding	11	11
Joint Laxity	10	10
Hematoma	10	10
Muscle Weakness	10	10
Headache	10	21
Loss of Range of Motion	9	9
Disability	9	9
Unspecified Mental, Emotional or Behavioural Problem	8	8
Burning Sensation	8	19
Weakness	8	8
Impaired Healing	8	8
Arthritis	8	8

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