TPLC - Total Product Life Cycle

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Device	joint, temporomandibular, implant
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	736	736
Device Dislodged or Dislocated	76	76
Malposition of Device	68	68
Patient Device Interaction Problem	64	64
Insufficient Information	54	54
Fracture	35	35
Inadequacy of Device Shape and/or Size	29	29
Noise, Audible	29	29
Patient-Device Incompatibility	27	27
Migration	25	25
Loosening of Implant Not Related to Bone-Ingrowth	22	22
Device Appears to Trigger Rejection	20	20
Migration or Expulsion of Device	16	16
Loss of Osseointegration	14	14
Positioning Problem	13	13
No Apparent Adverse Event	9	9
Difficult to Insert	7	7
Positioning Failure	7	7
Fitting Problem	6	6
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
Osseointegration Problem	4	4
Device-Device Incompatibility	2	2
Detachment of Device or Device Component	2	2
Nonstandard Device	2	2
Naturally Worn	2	2
Device Slipped	1	1
Unstable	1	1
Activation, Positioning or Separation Problem	1	1
Expiration Date Error	1	1
Contamination	1	1
Device Handling Problem	1	1
Unexpected Therapeutic Results	1	1
Connection Problem	1	1
Component Incompatible	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	330	330
Insufficient Information	166	166
Unspecified Infection	164	164
Loss of Range of Motion	115	115
No Clinical Signs, Symptoms or Conditions	115	115
Joint Dislocation	100	100
Swelling/ Edema	88	88
No Information	60	60
Failure of Implant	59	59
Ossification	58	58
Implant Pain	58	58
Ankylosis	56	56
Bacterial Infection	37	37
Hypersensitivity/Allergic reaction	34	34
Joint Disorder	27	27
Inadequate Pain Relief	22	22
Discomfort	20	20
Numbness	19	19
Difficulty Chewing	16	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	16	16
Inadequate Osseointegration	15	15
Scar Tissue	14	14
Swelling	14	14
Limited Mobility Of The Implanted Joint	14	14
Nerve Damage	13	13
Headache	13	13
Difficulty Chewing	12	12
Deformity/ Disfigurement	11	11
Obstruction/Occlusion	11	11
Osteolysis	9	9
Hearing Impairment	9	9
Joint Laxity	8	8
Bone Fracture(s)	8	8
Cramp(s) /Muscle Spasm(s)	8	8
Facial Nerve Paralysis	8	8
Itching Sensation	7	7
Feeding Problem	6	6
Bruxism	6	6
Fluid Discharge	6	6
Abscess	6	6
Reaction	6	6
Perforation	5	5
Fistula	5	5
Adhesion(s)	4	4
Rupture	4	4
Scar Excision	4	4
Metal Related Pathology	4	4
Neurological Deficit/Dysfunction	4	4
Hearing Loss	4	4
Paresthesia	4	4