TPLC - Total Product Life Cycle

show TPLC since

Device	joint, temporomandibular, implant
Regulation Description	Total temporomandibular joint prosthesis.
Definition	Call for PMAs to be filed by 3/30/99 per 63 FR 71746 on 12/30/98 - Indicated for reconstruction of the temporomandibular joint.
Product Code	LZD
Regulation Number	872.3940
Device Class	3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
2	1	1	1	2	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	794	794
Device Dislodged or Dislocated	86	86
Malposition of Device	72	72
Patient Device Interaction Problem	65	65
Insufficient Information	57	57
Fracture	36	36
Inadequacy of Device Shape and/or Size	34	34
Device Appears to Trigger Rejection	32	32
Patient-Device Incompatibility	30	30
Noise, Audible	29	29
Migration	26	26
Loosening of Implant Not Related to Bone-Ingrowth	25	25
Migration or Expulsion of Device	16	16
Loss of Osseointegration	15	15
Positioning Problem	13	13
No Apparent Adverse Event	10	10
Fitting Problem	10	10
Difficult to Insert	7	7
Positioning Failure	7	7
Material Integrity Problem	6	6
Appropriate Term/Code Not Available	6	6
Installation-Related Problem	5	5
Loose or Intermittent Connection	5	5
Use of Device Problem	4	4
Unintended Movement	4	4
Osseointegration Problem	4	4
Product Quality Problem	2	2
Detachment of Device or Device Component	2	2
Nonstandard Device	2	2
Naturally Worn	2	2
Component Incompatible	2	2
Device-Device Incompatibility	2	2
Component Missing	1	1
Contamination	1	1
Material Perforation	1	1
Use of Incorrect Control/Treatment Settings	1	1
Device Handling Problem	1	1
Expiration Date Error	1	1
Activation, Positioning or Separation Problem	1	1
Unstable	1	1
Device Slipped	1	1
Unexpected Therapeutic Results	1	1
Connection Problem	1	1
Flaked	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	357	357
Insufficient Information	190	190
Unspecified Infection	177	177
No Clinical Signs, Symptoms or Conditions	140	140
Loss of Range of Motion	124	124
Joint Dislocation	115	115
Swelling/ Edema	95	95
Ossification	61	61
Failure of Implant	61	61
No Information	60	60
Ankylosis	59	59
Implant Pain	59	59
Bacterial Infection	43	43
Hypersensitivity/Allergic reaction	36	36
Joint Disorder	27	27
Inadequate Pain Relief	22	22
Discomfort	21	21
Numbness	21	21
Difficulty Chewing	19	19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Inadequate Osseointegration	17	17
Scar Tissue	16	16
Headache	15	15
Obstruction/Occlusion	15	15
Swelling	14	14
Limited Mobility Of The Implanted Joint	14	14
Nerve Damage	14	14
Difficulty Chewing	12	12
Deformity/ Disfigurement	12	12
Osteolysis	10	10
Hearing Impairment	9	9
Cramp(s) /Muscle Spasm(s)	8	8
Bone Fracture(s)	8	8
Joint Laxity	8	8
Facial Nerve Paralysis	8	8
Itching Sensation	7	7
Fistula	7	7
Reaction	6	6
Abscess	6	6
Fluid Discharge	6	6
Bruxism	6	6
Feeding Problem	6	6
Perforation	5	5
Erythema	5	5
Peripheral Nervous Injury	4	4
Vertigo	4	4
Arthritis	4	4
Increased Sensitivity	4	4
Foreign Body In Patient	4	4
Paresthesia	4	4