TPLC - Total Product Life Cycle

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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	2026
2	1	1	1	2	1	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	871	871
Device Dislodged or Dislocated	106	106
Malposition of Device	84	86
Patient Device Interaction Problem	68	68
Nonstandard Device	67	67
Insufficient Information	61	61
Fracture	54	54
Device Appears to Trigger Rejection	53	53
Inadequacy of Device Shape and/or Size	41	41
Loosening of Implant Not Related to Bone-Ingrowth	35	35
Patient-Device Incompatibility	33	33
Noise, Audible	30	30
Migration	28	29
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
Loose or Intermittent Connection	5	5
Use of Device Problem	4	5
Unintended Movement	4	4
Osseointegration Problem	4	4
Detachment of Device or Device Component	3	3
Product Quality Problem	2	2
Naturally Worn	2	2
Component Incompatible	2	2
Improper or Incorrect Procedure or Method	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
Manufacturing, Packaging or Shipping 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
Inaccurate Information	1	1
Flaked	1	1
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	420	422
Insufficient Information	246	246
No Clinical Signs, Symptoms or Conditions	219	220
Unspecified Infection	200	200
Loss of Range of Motion	147	147
Joint Dislocation	131	131
Swelling/ Edema	111	111
Ankylosis	69	69
Ossification	66	66
Failure of Implant	61	61
No Information	60	60
Implant Pain	59	59
Bacterial Infection	53	53
Hypersensitivity/Allergic reaction	38	38
Joint Disorder	27	27
Discomfort	25	25
Difficulty Chewing	22	22
Inadequate Pain Relief	22	22
Numbness	21	23
Inadequate Osseointegration	20	20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Scar Tissue	17	17
Obstruction/Occlusion	16	16
Headache	15	15
Limited Mobility Of The Implanted Joint	14	14
Swelling	14	14
Nerve Damage	14	14
Deformity/ Disfigurement	12	12
Adhesion(s)	12	12
Difficulty Chewing	12	12
Fluid Discharge	10	10
Unspecified Musculoskeletal problem	10	10
Osteolysis	10	10
Fistula	10	10
Bone Fracture(s)	9	9
Hearing Impairment	9	9
Itching Sensation	9	9
Joint Laxity	8	8
Facial Nerve Paralysis	8	8
Cramp(s) /Muscle Spasm(s)	8	8
Bruxism	6	6
Feeding Problem	6	6
Reaction	6	6
Abscess	6	6
Perforation	6	6
Sensitivity of Teeth	5	5
Erythema	5	5
Vertigo	5	5
Rupture	4	4
Increased Sensitivity	4	4