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	715	719
Device Slipped	197	197
Adverse Event Without Identified Device or Use Problem	182	183
Device Dislodged or Dislocated	146	149
Loosening of Implant Not Related to Bone-Ingrowth	142	143
Material Deformation	138	138
Fracture	111	111
Migration	109	109
Mechanics Altered	66	67
Detachment of Device or Device Component	51	51
Device Appears to Trigger Rejection	46	46
Material Twisted/Bent	39	39
Mechanical Problem	38	38
Device-Device Incompatibility	32	32
Mechanical Jam	23	23
Use of Device Problem	19	19
Material Integrity Problem	16	16
Migration or Expulsion of Device	15	15
Unstable	14	15
Insufficient Information	13	15
Malposition of Device	12	12
No Apparent Adverse Event	12	12
Product Quality Problem	12	12
Patient-Device Incompatibility	12	14
Device Damaged by Another Device	12	13
Degraded	11	11
Failure to Osseointegrate	10	10
Entrapment of Device	10	10
Packaging Problem	9	9
Appropriate Term/Code Not Available	9	9
Material Separation	8	8
Crack	8	8
Compatibility Problem	8	8
Loose or Intermittent Connection	8	8
Patient Device Interaction Problem	6	6
Material Discolored	6	6
Biocompatibility	6	6
Material Fragmentation	5	5
Failure to Align	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Difficult to Advance	5	5
Scratched Material	4	4
Corroded	4	4
Defective Device	3	3
Wrong Label	3	3
Activation, Positioning or Separation Problem	3	3
Osseointegration Problem	3	3
Inadequate Instructions for Healthcare Professional	2	2
Therapeutic or Diagnostic Output Failure	2	2
Unintended Movement	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1256	1258
Pain	272	275
Failure of Implant	112	114
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	89	89
Insufficient Information	75	78
Implant Pain	65	65
Device Embedded In Tissue or Plaque	57	57
Unspecified Infection	46	47
Post Operative Wound Infection	39	39
Bone Fracture(s)	36	36
Inadequate Osseointegration	33	33
Foreign Body In Patient	27	27
Non-union Bone Fracture	25	26
Ambulation Difficulties	20	20
Numbness	18	18
Unspecified Nervous System Problem	16	16
Stenosis	15	15
Discomfort	15	16
Nerve Damage	14	14
Spinal Column Injury	13	13
Unspecified Tissue Injury	12	12
Neuropathy	11	11
Neck Pain	11	11
Spinal Cord Injury	10	10
Joint Laxity	10	10
Muscle Weakness	10	10
Osteolysis	10	10
Foreign Body Reaction	9	9
Hemorrhage/Bleeding	9	11
Paralysis	8	8
Unspecified Mental, Emotional or Behavioural Problem	8	8
Inflammation	8	8
Hematoma	8	8
Fall	8	8
Hypersensitivity/Allergic reaction	8	10
Impaired Healing	8	8
Purulent Discharge	7	7
Swelling/ Edema	7	7
Loss of Range of Motion	6	6
Intervertebral Disc Compression or Protrusion	6	7
Cerebrospinal Fluid Leakage	6	6
Headache	6	6
No Consequences Or Impact To Patient	5	5
Seroma	4	4
Anemia	4	4
Cyst(s)	4	4
Pleural Effusion	4	4
Arthritis	4	4
Pneumothorax	3	3
Unspecified Musculoskeletal problem	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	K2M, Inc	II	Mar-01-2022
2	K2M, Inc.	II	Jun-30-2022
3	Medtronic Sofamor Danek USA Inc	II	Apr-19-2023