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)
2021	2022	2023	2024	2025	2026
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	696	696
Device Dislodged or Dislocated	86	86
Malposition of Device	75	77
Nonstandard Device	67	67
Insufficient Device Problem Information	59	59
Device Appears to Trigger Rejection	57	57
Fracture	53	53
Patient Device Interaction Problem	46	46
Inadequacy of Device Shape and/or Size	43	43
Loosening of Implant Not Related to Bone-Ingrowth	30	30
Migration	26	27
Noise, Audible	22	22
Patient-Device Incompatibility	21	21
Loss of Osseointegration	19	19
No Apparent Adverse Event	10	10
Fitting Problem	10	10
Migration or Expulsion of Device	8	8
Positioning Problem	6	6
Positioning Failure	4	4
Detachment of Device or Device Component	4	4
Unintended Movement	4	4
Difficult to Insert	3	3
Osseointegration Problem	3	3
Use of Device Problem	2	2
Product Quality Problem	2	2
Naturally Worn	2	2
Component Incompatible	2	2
Device-Device Incompatibility	2	2
Component Missing	1	1
Material Perforation	1	1
Use of Incorrect Control/Treatment Settings	1	1
Device Handling Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Installation-Related Problem	1	1
Contamination	1	1
Expiration Date Error	1	1
Unstable	1	1
Connection Problem	1	1
Inaccurate Information	1	1
Flaked	1	1
Loose or Intermittent Connection	1	1
Improper or Incorrect Procedure or Method	1	1
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	366	368
Insufficient Information	269	269
No Clinical Signs, Symptoms or Conditions	211	212
Unspecified Infection	155	155
Loss of Range of Motion	134	134
Joint Dislocation	122	122
Swelling/ Edema	113	113
Ankylosis	67	67
Failure of Implant	57	57
Implant Pain	56	56
Bacterial Infection	53	53
Extraskeletal ossification	46	46
Hypersensitivity/Allergic reaction	28	28
Difficulty Chewing	23	23
Numbness	20	22
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	19	19
Inadequate Osseointegration	19	19
Discomfort	17	17
Obstruction/Occlusion	16	16
Deformity/ Disfigurement	12	12
Adhesion(s)	12	12
Unspecified Musculoskeletal problem	12	12
Scar Tissue	11	11
Hearing Impairment	11	11
Fluid Discharge	10	10
Osteolysis	10	10
Headache	9	9
Bone Fracture(s)	9	9
Aseptic loosening	9	9
Fistula	9	9
Joint Laxity	8	8
Cramp(s) /Muscle Spasm(s)	8	8
Itching Sensation	7	7
Ear Pain	7	7
Bruxism	6	6
No Information	5	5
Sensitivity of Teeth	5	5
Vertigo	5	5
Metal Related Pathology	4	4
Limited Mobility Of The Implanted Joint	4	4
Tinnitus	4	4
Hematoma	4	4
Abscess	4	4
Perforation	4	4
Speech Disorder	4	4
Partial Hearing Loss	4	4
Peripheral Nervous Injury	4	4
Rheumatoid Arthritis	4	4
Wound Dehiscence	4	4
Hyperresponsive to stimuli	4	4