Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 CodeLZD
Regulation Number 872.3940
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
1 2 1 1 1 0

MDR Year MDR Reports MDR Events
2019 204 204
2020 255 255
2021 207 207
2022 192 192
2023 236 236
2024 84 84

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 774 774
Device Dislodged or Dislocated 75 75
Patient Device Interaction Problem 67 67
Insufficient Information 66 66
Malposition of Device 60 60
Patient-Device Incompatibility 37 37
Noise, Audible 34 34
Fracture 32 32
Inadequacy of Device Shape and/or Size 29 29
Migration 26 26
Loosening of Implant Not Related to Bone-Ingrowth 24 24
Migration or Expulsion of Device 16 16
Device Appears to Trigger Rejection 15 15
Loose or Intermittent Connection 12 12
Positioning Problem 12 12
No Apparent Adverse Event 9 9
Material Integrity Problem 9 9
Loss of Osseointegration 8 8
Installation-Related Problem 7 7
Difficult to Insert 7 7
Positioning Failure 7 7
Appropriate Term/Code Not Available 6 6
Osseointegration Problem 5 5
Particulates 5 5
Fitting Problem 5 5
Material Erosion 4 4
Break 3 3
Use of Device Problem 3 3
Naturally Worn 3 3
Inaccurate Information 2 2
Material Protrusion/Extrusion 2 2
Detachment of Device or Device Component 2 2
Device-Device Incompatibility 2 2
Nonstandard Device 2 2
Device Slipped 1 1
Unexpected Therapeutic Results 1 1
Unstable 1 1
Component Incompatible 1 1
Contamination 1 1
Difficult or Delayed Positioning 1 1
Flaked 1 1
Expiration Date Error 1 1
Improper or Incorrect Procedure or Method 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 345 345
Unspecified Infection 181 181
Insufficient Information 140 140
No Clinical Signs, Symptoms or Conditions 105 105
Loss of Range of Motion 102 102
Joint Dislocation 89 89
No Information 81 81
Swelling/ Edema 77 77
Ossification 73 73
Failure of Implant 58 58
Implant Pain 56 56
Joint Disorder 55 55
Ankylosis 43 43
Swelling 38 38
Hypersensitivity/Allergic reaction 35 35
Nerve Damage 31 31
Bacterial Infection 31 31
No Code Available 30 30
Difficulty Chewing 30 30
Headache 23 23
Numbness 23 23
Discomfort 23 23
Inadequate Pain Relief 22 22
Limited Mobility Of The Implanted Joint 21 21
Scar Tissue 18 18
Inadequate Osseointegration 11 11
Difficulty Chewing 9 9
Reaction 9 9
Hearing Impairment 9 9
Bone Fracture(s) 8 8
Facial Nerve Paralysis 8 8
Osteolysis 8 8
Deformity/ Disfigurement 8 8
Cramp(s) /Muscle Spasm(s) 8 8
No Known Impact Or Consequence To Patient 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Obstruction/Occlusion 7 7
Joint Laxity 7 7
Sleep Dysfunction 6 6
Blurred Vision 6 6
Feeding Problem 6 6
Abscess 6 6
Hematoma 6 6
Erythema 6 6
Itching Sensation 5 5
Fistula 5 5
Perforation 5 5
Dysphasia 5 5
Sensitivity of Teeth 5 5
Fibrosis 5 5
Foreign Body In Patient 4 4
Metal Related Pathology 4 4
Increased Sensitivity 4 4
Rupture 4 4
Arthralgia 4 4
Scar Excision 4 4
Vertigo 4 4
Necrosis 4 4
Dysphagia/ Odynophagia 4 4
Adhesion(s) 4 4
Arthritis 4 4
Rheumatoid Arthritis 4 4
Neurological Deficit/Dysfunction 4 4
Hearing Loss 4 4
Inflammation 3 3
Wound Dehiscence 3 3
Purulent Discharge 3 3
Foreign Body Reaction 3 3
Tinnitus 3 3
No Consequences Or Impact To Patient 3 3
Drug Resistant Bacterial Infection 3 3
Eye Pain 3 3
Osteopenia/ Osteoporosis 3 3
No Patient Involvement 2 2
Post Operative Wound Infection 2 2
Fluid Discharge 2 2
Cancer 2 2
Bruxism 2 2
Osteomyelitis 2 2
Skin Inflammation/ Irritation 2 2
Urticaria 2 2
Non-union Bone Fracture 2 2
Irritability 2 2
Rash 2 2
Pocket Erosion 2 2
Scarring 2 2
Seizures 2 2
Increased Sensitivity 2 2
Skin Discoloration 2 2
Edema 2 2
Autoimmune Reaction 2 2
Laceration(s) 2 2
Muscle Weakness 2 2
Granuloma 2 2
High Blood Pressure/ Hypertension 2 2
Low Blood Pressure/ Hypotension 1 1
Hemorrhage/Bleeding 1 1
Erosion 1 1
Cellulitis 1 1
Airway Obstruction 1 1

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