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	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	834	834
Device Dislodged or Dislocated	94	94
Malposition of Device	79	79
Patient Device Interaction Problem	65	65
Insufficient Information	57	57
Fracture	51	51
Inadequacy of Device Shape and/or Size	37	37
Device Appears to Trigger Rejection	35	35
Loosening of Implant Not Related to Bone-Ingrowth	32	32
Patient-Device Incompatibility	30	30
Noise, Audible	29	29
Migration	26	26
Loss of Osseointegration	19	19
Migration or Expulsion of Device	16	16
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
Nonstandard Device	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
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	388	388
Insufficient Information	218	218
Unspecified Infection	188	188
No Clinical Signs, Symptoms or Conditions	149	149
Loss of Range of Motion	132	132
Joint Dislocation	120	120
Swelling/ Edema	106	106
Ossification	66	66
Ankylosis	63	63
Failure of Implant	61	61
No Information	60	60
Implant Pain	59	59
Bacterial Infection	47	47
Hypersensitivity/Allergic reaction	37	37
Joint Disorder	27	27
Inadequate Pain Relief	22	22
Discomfort	21	21
Numbness	21	21
Inadequate Osseointegration	20	20
Difficulty Chewing	20	20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Scar Tissue	16	16
Headache	15	15
Obstruction/Occlusion	15	15
Limited Mobility Of The Implanted Joint	14	14
Swelling	14	14
Nerve Damage	14	14
Deformity/ Disfigurement	12	12
Difficulty Chewing	12	12
Fluid Discharge	10	10
Osteolysis	10	10
Fistula	9	9
Hearing Impairment	9	9
Joint Laxity	8	8
Facial Nerve Paralysis	8	8
Bone Fracture(s)	8	8
Cramp(s) /Muscle Spasm(s)	8	8
Itching Sensation	7	7
Bruxism	6	6
Reaction	6	6
Abscess	6	6
Feeding Problem	6	6
Sensitivity of Teeth	5	5
Erythema	5	5
Perforation	5	5
Rupture	4	4
Increased Sensitivity	4	4
Arthritis	4	4
Wound Dehiscence	4	4
Neurological Deficit/Dysfunction	4	4