TPLC - Total Product Life Cycle

show TPLC since

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	753	757
Adverse Event Without Identified Device or Use Problem	208	209
Device Slipped	198	198
Loosening of Implant Not Related to Bone-Ingrowth	175	176
Device Dislodged or Dislocated	166	169
Material Deformation	163	163
Fracture	118	118
Migration	113	113
Mechanics Altered	69	70
Detachment of Device or Device Component	61	61
Mechanical Problem	57	57
Device Appears to Trigger Rejection	47	47
Material Twisted/Bent	40	40
Device-Device Incompatibility	33	33
Product Quality Problem	30	30
Device Damaged by Another Device	28	29
Malposition of Device	25	25
Mechanical Jam	24	24
Use of Device Problem	19	19
Material Integrity Problem	16	16
Migration or Expulsion of Device	15	15
Unstable	14	15
Insufficient Information	14	16
Patient-Device Incompatibility	13	15
No Apparent Adverse Event	13	13
Degraded	11	11
Entrapment of Device	10	10
Failure to Osseointegrate	10	10
Loose or Intermittent Connection	9	9
Appropriate Term/Code Not Available	9	9
Packaging Problem	9	9
Osseointegration Problem	8	8
Crack	8	8
Compatibility Problem	8	8
Material Separation	8	8
Failure to Align	8	8
Biocompatibility	6	6
Material Discolored	6	6
Patient Device Interaction Problem	6	6
Material Fragmentation	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
Physical Resistance/Sticking	3	3
Difficult to Remove	2	2
Inadequate Instructions for Healthcare Professional	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1362	1364
Pain	310	313
Failure of Implant	112	114
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	97	97
Insufficient Information	79	82
Implant Pain	65	65
Device Embedded In Tissue or Plaque	59	59
Unspecified Infection	53	54
Bone Fracture(s)	47	47
Inadequate Osseointegration	41	41
Post Operative Wound Infection	40	40
Foreign Body In Patient	27	27
Non-union Bone Fracture	27	28
Unspecified Nervous System Problem	21	21
Numbness	20	20
Ambulation Difficulties	20	20
Stenosis	20	20
Discomfort	16	17
Neck Pain	16	16
Neuropathy	15	15
Nerve Damage	14	14
Spinal Column Injury	14	14
Unspecified Tissue Injury	13	13
Dysphasia	11	11
Difficulty Chewing	11	11
Spinal Cord Injury	11	11
Hemorrhage/Bleeding	11	13
Osteolysis	10	10
Muscle Weakness	10	10
Joint Laxity	10	10
Intervertebral Disc Compression or Protrusion	10	11
Foreign Body Reaction	9	9
Fall	8	8
Unspecified Mental, Emotional or Behavioural Problem	8	8
Paralysis	8	8
Inflammation	8	8
Hematoma	8	8
Hypersensitivity/Allergic reaction	8	10
Impaired Healing	8	8
Purulent Discharge	7	7
Swelling/ Edema	7	7
Cerebrospinal Fluid Leakage	6	6
Headache	6	6
Loss of Range of Motion	6	6
No Consequences Or Impact To Patient	5	5
Anemia	4	4
Unspecified Musculoskeletal problem	4	4
Seroma	4	4
Arthritis	4	4
Pleural Effusion	4	4

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