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	923	931
Adverse Event Without Identified Device or Use Problem	349	361
Device Slipped	268	268
Loosening of Implant Not Related to Bone-Ingrowth	204	205
Material Deformation	189	189
Device Dislodged or Dislocated	169	172
Migration	166	166
Fracture	139	139
Mechanics Altered	73	74
Detachment of Device or Device Component	56	56
Mechanical Problem	47	47
Migration or Expulsion of Device	46	46
Device Appears to Trigger Rejection	46	46
Material Twisted/Bent	41	41
Device-Device Incompatibility	40	40
Mechanical Jam	32	32
No Apparent Adverse Event	30	30
Failure to Align	25	25
Loose or Intermittent Connection	25	25
Malposition of Device	25	25
Use of Device Problem	22	22
Material Integrity Problem	21	21
Device Damaged by Another Device	19	20
Patient-Device Incompatibility	14	16
Unstable	14	15
Insufficient Information	13	15
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
Crack	9	9
Material Separation	9	9
Packaging Problem	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
Material Discolored	6	6
Difficult to Advance	5	5
Unintended Movement	4	4
Corroded	4	4
Defective Device	4	4
Nonstandard Device	3	3
Failure to Advance	3	3
Inadequacy of Device Shape and/or Size	3	3
Osseointegration Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1371	1373
Pain	409	427
No Known Impact Or Consequence To Patient	291	291
Failure of Implant	162	167
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	89	89
Insufficient Information	82	85
Device Embedded In Tissue or Plaque	72	72
Seroma	68	68
Implant Pain	65	65
Unspecified Infection	60	61
Bone Fracture(s)	57	57
No Code Available	55	55
Post Operative Wound Infection	43	43
Foreign Body In Patient	40	40
No Patient Involvement	38	38
Non-union Bone Fracture	37	38
Injury	35	35
Inadequate Osseointegration	33	33
Numbness	29	40
Stenosis	28	28
Ambulation Difficulties	25	25
Spinal Column Injury	24	24
Spinal Cord Injury	21	21
No Consequences Or Impact To Patient	19	19
Nerve Damage	18	18
Paralysis	18	18
Patient Problem/Medical Problem	18	18
Discomfort	17	18
Unspecified Nervous System Problem	17	17
Neurological Deficit/Dysfunction	16	16
Neck Pain	16	16
Neuropathy	16	16
Foreign Body Reaction	13	13
Inflammation	13	13
Cerebrospinal Fluid Leakage	12	12
Fall	12	12
Unspecified Tissue Injury	12	12
Osteolysis	11	11
Hemorrhage/Bleeding	11	13
Joint Laxity	10	10
Headache	10	21
Hematoma	10	10
Muscle Weakness	10	10
Disability	9	9
Loss of Range of Motion	9	9
Hypersensitivity/Allergic reaction	9	11
Weakness	8	8
Burning Sensation	8	19
Unspecified Mental, Emotional or Behavioural Problem	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