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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthopedic manual surgical instrument
Product CodeLXH
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
SONEX HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 5224 5233
2020 4766 4771
2021 4833 4884
2022 4844 4912
2023 5183 5196
2024 2777 2777

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10572 10572
Device-Device Incompatibility 4005 4005
Fracture 2847 2878
Material Deformation 1438 1476
Material Twisted/Bent 1289 1289
Detachment of Device or Device Component 1263 1263
Naturally Worn 1157 1157
Crack 917 917
Mechanical Jam 762 808
Scratched Material 611 611
Mechanical Problem 585 585
Calibration Problem 496 496
Physical Resistance/Sticking 446 446
Adverse Event Without Identified Device or Use Problem 439 441
Material Integrity Problem 384 384
Material Fragmentation 366 366
Corroded 332 338
Contamination /Decontamination Problem 312 312
Mechanics Altered 304 304
Use of Device Problem 216 216
Unintended Movement 214 214
Appropriate Term/Code Not Available 202 202
Entrapment of Device 184 184
Difficult to Open or Close 174 174
Loose or Intermittent Connection 172 172
Difficult to Remove 164 164
Illegible Information 161 161
Component Missing 151 151
Compatibility Problem 148 148
Defective Device 145 145
Dull, Blunt 141 141
Material Separation 128 128
No Apparent Adverse Event 128 128
Connection Problem 121 121
Insufficient Information 108 108
Degraded 102 102
Failure to Align 100 100
Material Discolored 93 93
Device Slipped 86 86
Failure to Advance 80 80
Material Split, Cut or Torn 75 75
Positioning Failure 73 73
Device Contamination with Chemical or Other Material 62 62
Difficult to Advance 60 60
Difficult to Insert 59 59
Device Dislodged or Dislocated 56 56
Flaked 54 54
Unstable 51 51
Manufacturing, Packaging or Shipping Problem 49 49
Improper or Incorrect Procedure or Method 45 45
Fitting Problem 44 44
Separation Failure 38 38
Device Damaged by Another Device 37 37
Deformation Due to Compressive Stress 37 48
Difficult or Delayed Separation 37 37
Device Damaged Prior to Use 36 36
Device Difficult to Setup or Prepare 35 35
Positioning Problem 34 34
Peeled/Delaminated 33 33
Structural Problem 31 31
Device Markings/Labelling Problem 31 31
Material Disintegration 29 29
Device Contaminated During Manufacture or Shipping 28 28
Solder Joint Fracture 28 28
Failure to Cut 27 27
Patient Device Interaction Problem 27 27
Loosening of Implant Not Related to Bone-Ingrowth 23 23
Device Fell 23 23
Activation, Positioning or Separation Problem 23 23
Display Difficult to Read 22 22
Incorrect Measurement 22 22
Difficult or Delayed Positioning 21 21
Migration 21 21
Incomplete or Inadequate Connection 21 21
Migration or Expulsion of Device 20 20
Residue After Decontamination 18 18
Defective Component 17 17
Problem with Sterilization 17 17
Failure to Clean Adequately 17 17
Failure to Eject 17 43
Device Difficult to Maintain 17 17
Output Problem 16 16
Delivered as Unsterile Product 16 16
Off-Label Use 16 16
Product Quality Problem 15 15
Material Frayed 13 13
Malposition of Device 13 13
Packaging Problem 13 13
Inadequacy of Device Shape and/or Size 12 12
Nonstandard Device 11 11
Failure to Disconnect 11 11
Human-Device Interface Problem 11 11
Separation Problem 11 11
Inaccurate Information 10 10
Noise, Audible 10 10
Device Handling Problem 10 10
Material Protrusion/Extrusion 10 10
Patient-Device Incompatibility 10 10
Loss of Osseointegration 9 9
Component or Accessory Incompatibility 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16132 16264
No Consequences Or Impact To Patient 5512 5526
No Known Impact Or Consequence To Patient 1586 1586
Insufficient Information 1382 1384
Foreign Body In Patient 882 882
No Patient Involvement 766 766
No Code Available 594 594
Not Applicable 331 331
Device Embedded In Tissue or Plaque 275 275
No Information 160 160
Bone Fracture(s) 136 136
Failure of Implant 110 110
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 109 109
Injury 106 106
Pain 93 93
Unspecified Infection 72 72
Unspecified Tissue Injury 55 55
Tissue Damage 39 39
Loss of Range of Motion 31 31
Nerve Damage 26 26
Laceration(s) 25 25
Joint Dislocation 25 25
Non-union Bone Fracture 21 21
Hemorrhage/Bleeding 20 20
Spinal Column Injury 19 19
Perforation 18 18
Inflammation 17 17
Swelling/ Edema 15 15
Muscle/Tendon Damage 14 14
Limb Fracture 12 12
Subluxation 11 11
Patient Problem/Medical Problem 11 11
Post Operative Wound Infection 11 11
Fluid Discharge 10 10
Rheumatoid Arthritis 10 10
Joint Laxity 9 9
Ambulation Difficulties 9 9
Blood Loss 9 9
Rupture 8 8
Implant Pain 8 8
Bacterial Infection 8 8
Hypersensitivity/Allergic reaction 8 8
Perforation of Vessels 7 7
Burn(s) 7 7
Hip Fracture 7 7
Discomfort 7 7
Arthralgia 7 7
Osteolysis 6 6
Weakness 6 6
Numbness 6 6
Spinal Cord Injury 6 6
Scar Tissue 6 6
Paralysis 6 6
Hematoma 6 6
Muscular Rigidity 6 6
Neurological Deficit/Dysfunction 5 5
Necrosis 5 5
Osteopenia/ Osteoporosis 5 5
Disc Impingement 5 5
Impaired Healing 5 5
Reaction 5 5
Deformity/ Disfigurement 4 4
Limited Mobility Of The Implanted Joint 4 4
Inadequate Osseointegration 4 4
Fall 4 4
Foreign Body Reaction 4 4
Connective Tissue Disease 3 3
Purulent Discharge 3 3
Vessel Or Plaque, Device Embedded In 3 3
Abscess 3 3
Adhesion(s) 3 3
Neuropathy 3 3
Myocardial Infarction 3 3
Damage to Ligament(s) 3 3
Muscle Weakness 3 3
Infiltration into Tissue 3 3
Unspecified Musculoskeletal problem 3 3
External Prosthetic Device Pain 2 2
Unintended Radiation Exposure 2 2
Malunion of Bone 2 2
Hyperextension 2 2
Neuralgia 2 2
Paresthesia 2 2
Intraoperative Pain 2 2
Paraplegia 2 2
Quadriplegia 2 2
Needle Stick/Puncture 2 2
Great Vessel Perforation 2 2
Seroma 2 2
Irritation 2 2
Headache 2 2
Internal Organ Perforation 2 2
Overdose 2 2
Rash 2 2
Swelling 2 2
Synovitis 2 2
Thrombosis 2 2
Pulmonary Embolism 2 2
Wound Dehiscence 2 2
Cardiac Arrest 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Dec-26-2023
2 Aesculap Implant Systems LLC II Jul-21-2022
3 Aesculap Implant Systems LLC II Jul-21-2022
4 Aesculap Implant Systems LLC II Jul-15-2022
5 Arthrex, Inc. II May-05-2022
6 Arthrex, Inc. II Jan-30-2020
7 Biomet II Jun-12-2020
8 ConMed Corporation II Apr-27-2021
9 ConMed Corporation II Dec-21-2020
10 DePuy Orthopaedics, Inc. II Apr-11-2019
11 Encore Medical, Lp II Dec-06-2019
12 Howmedica Osteonics Corp. II Feb-06-2024
13 Howmedica Osteonics Corp. II Jun-14-2023
14 In2bones USA, LLC II Sep-22-2021
15 K2M, Inc II Dec-07-2020
16 Laboratoires Bodycad, Inc. II Nov-17-2021
17 Medacta Usa Inc II Jun-07-2022
18 Medtronic Sofamor Danek USA Inc II May-10-2023
19 Mizuho OSI II Aug-24-2022
20 OMNIlife science Inc. II Feb-14-2019
21 Pega Medical Inc. III May-15-2020
22 Pega Medical Inc. II Nov-01-2019
23 SONEX HEALTH LLC II Jul-15-2022
24 Smith & Nephew, Inc. II Aug-10-2020
25 Smith & Nephew, Inc. II Nov-08-2019
26 Smith & Nephew, Inc. II Jan-12-2019
27 Stryker Spine II Dec-21-2023
28 Synthes (USA) Products LLC II Feb-10-2022
29 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Jul-03-2023
30 TeDan Surgical Innovations LLC II Jul-10-2020
31 TeDan Surgical Innovations LLC II Mar-17-2020
32 Tornier, Inc II Jun-01-2022
33 TriMed Inc. II Nov-12-2019
34 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-29-2023
35 Zimmer Biomet, Inc. II Jun-02-2020
36 Zimmer Biomet, Inc. II Jan-28-2020
37 Zimmer Biomet, Inc. II Dec-03-2019
38 Zimmer Biomet, Inc. II Nov-22-2019
39 Zimmer Biomet, Inc. II Nov-07-2019
40 Zimmer Biomet, Inc. II Jul-04-2019
41 Zimmer Biomet, Inc. II Jun-19-2019
42 Zimmer Biomet, Inc. II Jun-06-2019
43 restor3d Inc. II Apr-29-2022
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