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	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	679	679
Device Dislodged or Dislocated	83	83
Malposition of Device	69	71
Insufficient Information	56	56
Fracture	51	51
Patient Device Interaction Problem	44	44
Device Appears to Trigger Rejection	38	38
Inadequacy of Device Shape and/or Size	36	36
Nonstandard Device	31	31
Loosening of Implant Not Related to Bone-Ingrowth	27	27
Noise, Audible	21	21
Patient-Device Incompatibility	21	21
Loss of Osseointegration	19	19
Migration	15	16
No Apparent Adverse Event	10	10
Fitting Problem	10	10
Positioning Problem	8	8
Migration or Expulsion of Device	7	7
Appropriate Term/Code Not Available	6	6
Use of Device Problem	4	5
Unintended Movement	4	4
Positioning Failure	3	3
Difficult to Insert	3	3
Detachment of Device or Device Component	3	3
Osseointegration Problem	3	3
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
Contamination	1	1
Installation-Related Problem	1	1
Expiration Date Error	1	1
Unstable	1	1
Device Slipped	1	1
Unexpected Therapeutic Results	1	1
Connection Problem	1	1
Flaked	1	1
Loose or Intermittent Connection	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	334	336
Insufficient Information	220	220
No Clinical Signs, Symptoms or Conditions	166	167
Unspecified Infection	144	144
Loss of Range of Motion	119	119
Joint Dislocation	111	111
Swelling/ Edema	106	106
Ankylosis	59	59
Failure of Implant	57	57
Implant Pain	56	56
Bacterial Infection	46	46
Ossification	45	45
Hypersensitivity/Allergic reaction	27	27
Difficulty Chewing	20	20
Numbness	20	22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Inadequate Osseointegration	18	18
Obstruction/Occlusion	15	15
Deformity/ Disfigurement	12	12
Discomfort	11	11
Osteolysis	10	10
Scar Tissue	10	10
Fluid Discharge	10	10
Hearing Impairment	9	9
Headache	9	9
Fistula	8	8
Joint Laxity	8	8
Cramp(s) /Muscle Spasm(s)	8	8
Bone Fracture(s)	7	7
Bruxism	6	6
Vertigo	5	5
Itching Sensation	5	5
Unspecified Musculoskeletal problem	5	5
No Information	5	5
Sensitivity of Teeth	5	5
Adhesion(s)	4	4
Abscess	4	4
Hematoma	4	4
Peripheral Nervous Injury	4	4
Metal Related Pathology	4	4
Limited Mobility Of The Implanted Joint	4	4
Speech Disorder	4	4
Wound Dehiscence	4	4
Paresthesia	4	4
Rheumatoid Arthritis	4	4
Increased Sensitivity	4	4
Eye Pain	3	3
Tinnitus	3	3
Erythema	3	3
Nerve Damage	3	3