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)
2019	2020	2021	2022	2023	2024
1	2	1	1	1	2

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	82	82
Malposition of Device	67	67
Patient Device Interaction Problem	67	67
Insufficient Information	66	66
Noise, Audible	39	39
Fracture	37	37
Patient-Device Incompatibility	37	37
Inadequacy of Device Shape and/or Size	36	36
Loosening of Implant Not Related to Bone-Ingrowth	28	28
Migration	27	27
Device Appears to Trigger Rejection	19	19
Migration or Expulsion of Device	16	16
Loss of Osseointegration	14	14
Positioning Problem	13	13
Loose or Intermittent Connection	12	12
Material Integrity Problem	9	9
No Apparent Adverse Event	9	9
Installation-Related Problem	7	7
Positioning Failure	7	7
Difficult to Insert	7	7
Appropriate Term/Code Not Available	6	6
Particulates	5	5
Osseointegration Problem	5	5
Fitting Problem	5	5
Use of Device Problem	4	4
Material Erosion	4	4
Break	3	3
Naturally Worn	3	3
Detachment of Device or Device Component	2	2
Material Protrusion/Extrusion	2	2
Nonstandard Device	2	2
Inaccurate Information	2	2
Device-Device Incompatibility	2	2
Difficult or Delayed Positioning	1	1
Device Handling Problem	1	1
Contamination	1	1
Expiration Date Error	1	1
Activation, Positioning or Separation Problem	1	1
Unstable	1	1
Unexpected Therapeutic Results	1	1
Connection Problem	1	1
Component Incompatible	1	1
Device Slipped	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	361	361
Unspecified Infection	193	193
Insufficient Information	159	159
Loss of Range of Motion	114	114
No Clinical Signs, Symptoms or Conditions	110	110
Joint Dislocation	101	101
Swelling/ Edema	88	88
No Information	81	81
Ossification	73	73
Failure of Implant	62	62
Implant Pain	58	58
Joint Disorder	55	55
Ankylosis	50	50
Swelling	38	38
Hypersensitivity/Allergic reaction	37	37
Bacterial Infection	36	36
Nerve Damage	31	31
Difficulty Chewing	30	30
No Code Available	30	30
Numbness	27	27
Discomfort	26	26
Headache	23	23
Inadequate Pain Relief	22	22
Limited Mobility Of The Implanted Joint	21	21
Scar Tissue	18	18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Inadequate Osseointegration	14	14
Difficulty Chewing	13	13
Obstruction/Occlusion	11	11
Deformity/ Disfigurement	10	10
Reaction	9	9
Osteolysis	9	9
Hearing Impairment	9	9
No Known Impact Or Consequence To Patient	8	8
Bone Fracture(s)	8	8
Cramp(s) /Muscle Spasm(s)	8	8
Facial Nerve Paralysis	8	8
Joint Laxity	7	7
Bruxism	6	6
Abscess	6	6
Feeding Problem	6	6
Erythema	6	6
Blurred Vision	6	6
Itching Sensation	6	6
Hematoma	6	6
Sleep Dysfunction	6	6
Perforation	5	5
Fibrosis	5	5
Sensitivity of Teeth	5	5
Fistula	5	5

Recalls
Manufacturer		Recall Class	Date Posted
1	Stryker Leibinger GmbH & Co. KG	II	Mar-08-2023