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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
2018 4685 4685
2019 5224 5233
2020 4766 4771
2021 4833 4884
2022 4844 4912
2023 5178 5191
2024 445 445

Device Problems MDRs with this Device Problem Events in those MDRs
Break 11697 11697
Device-Device Incompatibility 3908 3908
Fracture 2972 3003
Material Deformation 1474 1512
Material Twisted/Bent 1340 1340
Detachment of Device or Device Component 1267 1267
Naturally Worn 1251 1251
Crack 1184 1184
Mechanical Jam 870 916
Scratched Material 839 839
Mechanical Problem 639 639
Calibration Problem 506 506
Adverse Event Without Identified Device or Use Problem 488 490
Appropriate Term/Code Not Available 417 417
Material Integrity Problem 387 387
Material Fragmentation 369 369
Physical Resistance/Sticking 319 319
Corroded 315 321
Contamination /Decontamination Problem 292 292
Mechanics Altered 261 261
Difficult to Remove 247 247
Component Missing 221 221
Loose or Intermittent Connection 216 216
Entrapment of Device 207 207
Unintended Movement 206 206
Use of Device Problem 193 193
Illegible Information 156 156
Dull, Blunt 151 151
Insufficient Information 148 148
Compatibility Problem 148 148
Difficult to Open or Close 147 147
Connection Problem 145 145
Device Operates Differently Than Expected 136 136
Device Contamination with Chemical or Other Material 116 116
Failure to Align 111 111
Defective Device 109 109
Material Discolored 104 104
Degraded 102 102
Material Separation 102 102
Device Slipped 101 101
Bent 89 89
Positioning Failure 79 79
Material Split, Cut or Torn 76 76
Difficult to Insert 73 73
No Apparent Adverse Event 71 71
Detachment Of Device Component 66 66
Failure to Advance 60 60
Device Dislodged or Dislocated 58 58
Manufacturing, Packaging or Shipping Problem 57 57
Separation Failure 57 57
Flaked 54 54
Positioning Problem 52 52
Improper or Incorrect Procedure or Method 51 51
Difficult to Advance 50 50
Device Damaged Prior to Use 47 47
Fitting Problem 44 44
Unstable 40 40
Deformation Due to Compressive Stress 40 51
Device Damaged by Another Device 40 40
Peeled/Delaminated 38 38
Device Markings/Labelling Problem 35 35
Material Disintegration 33 33
Difficult or Delayed Separation 33 33
Device Difficult to Setup or Prepare 32 32
Solder Joint Fracture 31 31
Device Fell 30 30
Structural Problem 28 28
Failure to Cut 27 27
Metal Shedding Debris 26 26
Patient Device Interaction Problem 26 26
Device Contaminated During Manufacture or Shipping 26 26
Incorrect Measurement 25 25
Migration or Expulsion of Device 25 25
Activation, Positioning or Separation Problem 24 24
Loosening of Implant Not Related to Bone-Ingrowth 24 24
Incomplete or Inadequate Connection 23 23
Defective Component 22 22
Display Difficult to Read 22 22
Difficult or Delayed Positioning 21 21
Residue After Decontamination 21 21
Inadequacy of Device Shape and/or Size 20 20
Migration 20 20
Device Issue 19 19
Failure to Disconnect 19 19
Problem with Sterilization 18 18
Device Reprocessing Problem 18 18
Device Difficult to Maintain 18 18
Separation Problem 18 18
Failure to Eject 17 43
Packaging Problem 17 17
Failure to Clean Adequately 17 17
Off-Label Use 17 17
Nonstandard Device 17 17
Delivered as Unsterile Product 17 17
Output Problem 15 15
Device Handling Problem 14 14
Malposition of Device 14 14
Patient-Device Incompatibility 14 14
Device Inoperable 12 12
Noise, Audible 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14286 14418
No Consequences Or Impact To Patient 8274 8288
No Known Impact Or Consequence To Patient 2506 2506
No Patient Involvement 1019 1019
Insufficient Information 992 994
Foreign Body In Patient 941 941
No Code Available 814 814
Not Applicable 467 467
Device Embedded In Tissue or Plaque 365 365
No Information 364 364
Bone Fracture(s) 170 170
Injury 130 130
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 106 106
Pain 102 102
Failure of Implant 95 95
Unspecified Infection 87 87
Tissue Damage 52 52
Unspecified Tissue Injury 52 52
Loss of Range of Motion 30 30
Nerve Damage 27 27
Laceration(s) 24 24
Non-union Bone Fracture 23 23
Joint Dislocation 23 23
Hemorrhage/Bleeding 19 19
Inflammation 17 17
Perforation 16 16
Patient Problem/Medical Problem 15 15
Swelling/ Edema 15 15
Pulmonary Embolism 14 14
Death 13 13
Post Operative Wound Infection 13 13
Muscle/Tendon Damage 13 13
Blood Loss 12 12
Hip Fracture 12 12
Subluxation 11 11
Limb Fracture 10 10
Discomfort 10 10
Fluid Discharge 10 10
Rheumatoid Arthritis 10 10
Ambulation Difficulties 9 9
Rupture 9 9
Joint Laxity 9 9
Implant Pain 8 8
Perforation of Vessels 8 8
Bacterial Infection 8 8
Burn(s) 8 8
Paralysis 8 8
Foreign Body Reaction 8 8
Hematoma 7 7
Weakness 7 7
Scar Tissue 7 7
Spinal Column Injury 7 7
Arthralgia 7 7
Numbness 7 7
Spinal Cord Injury 6 6
Osteolysis 6 6
Impaired Healing 6 6
Necrosis 6 6
Muscular Rigidity 6 6
Neurological Deficit/Dysfunction 5 5
Reaction 5 5
Disc Impingement 5 5
Inadequate Osseointegration 4 4
Limited Mobility Of The Implanted Joint 4 4
Deformity/ Disfigurement 4 4
Swelling 4 4
Neuropathy 4 4
Hypersensitivity/Allergic reaction 4 4
Damage to Ligament(s) 4 4
Cardiac Arrest 4 4
Fall 4 4
Connective Tissue Disease 3 3
Purulent Discharge 3 3
Vessel Or Plaque, Device Embedded In 3 3
Arthritis 3 3
Abscess 3 3
Adhesion(s) 3 3
Muscle Weakness 3 3
Infiltration into Tissue 3 3
Myocardial Infarction 3 3
Local Reaction 3 3
Skin Irritation 3 3
Osteopenia/ Osteoporosis 3 3
Paraplegia 2 2
Quadriplegia 2 2
Needle Stick/Puncture 2 2
Intraoperative Pain 2 2
Paresthesia 2 2
Joint Disorder 2 2
Seroma 2 2
Synovitis 2 2
Thrombosis 2 2
Great Vessel Perforation 2 2
Internal Organ Perforation 2 2
Overdose 2 2
Rash 2 2
Irritation 2 2
Headache 2 2
Wound Dehiscence 2 2
Dysphagia/ Odynophagia 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Dec-26-2023
2 Ad-Tech Medical Instrument Corporation II May-25-2018
3 Aesculap Implant Systems LLC II Jul-21-2022
4 Aesculap Implant Systems LLC II Jul-21-2022
5 Aesculap Implant Systems LLC II Jul-15-2022
6 Arthrex, Inc. II May-05-2022
7 Arthrex, Inc. II Jan-30-2020
8 Biomet II Jun-12-2020
9 ConMed Corporation II Apr-27-2021
10 ConMed Corporation II Dec-21-2020
11 DePuy Mitek, Inc., a Johnson & Johnson Co. II Oct-23-2018
12 DePuy Mitek, Inc., a Johnson & Johnson Co. II May-08-2018
13 DePuy Orthopaedics, Inc. II Apr-11-2019
14 DePuy Orthopaedics, Inc. II Mar-02-2018
15 Encore Medical, Lp II Dec-06-2019
16 Exactech, Inc. II Oct-11-2018
17 Howmedica Osteonics Corp. II Feb-06-2024
18 Howmedica Osteonics Corp. II Jun-14-2023
19 Howmedica Osteonics Corp. II Dec-21-2018
20 Howmedica Osteonics Corp. II Nov-02-2018
21 Howmedica Osteonics Corp. II Oct-23-2018
22 Howmedica Osteonics Corp. II Mar-01-2018
23 In2bones USA, LLC II Sep-22-2021
24 K2M, Inc II Dec-07-2020
25 Laboratoires Bodycad, Inc. II Nov-17-2021
26 Medacta Usa Inc II Jun-07-2022
27 Medtronic Sofamor Danek USA Inc II May-10-2023
28 Mizuho OSI II Aug-24-2022
29 OMNIlife science Inc. II Feb-14-2019
30 Pega Medical Inc. III May-15-2020
31 Pega Medical Inc. II Nov-01-2019
32 SONEX HEALTH LLC II Jul-15-2022
33 Smith & Nephew, Inc. II Aug-10-2020
34 Smith & Nephew, Inc. II Nov-08-2019
35 Smith & Nephew, Inc. II Jan-12-2019
36 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
37 Stryker Spine II Dec-21-2023
38 Synthes (USA) Products LLC II Feb-10-2022
39 Synthes, Inc. II Apr-24-2018
40 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Jul-03-2023
41 TeDan Surgical Innovations LLC II Jul-10-2020
42 TeDan Surgical Innovations LLC II Mar-17-2020
43 Tornier, Inc II Jun-01-2022
44 TriMed Inc. II Nov-12-2019
45 TriMed Inc. II Apr-12-2018
46 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-29-2023
47 Zimmer Biomet, Inc. II Jun-02-2020
48 Zimmer Biomet, Inc. II Jan-28-2020
49 Zimmer Biomet, Inc. II Dec-03-2019
50 Zimmer Biomet, Inc. II Nov-22-2019
51 Zimmer Biomet, Inc. II Nov-07-2019
52 Zimmer Biomet, Inc. II Jul-04-2019
53 Zimmer Biomet, Inc. II Jun-19-2019
54 Zimmer Biomet, Inc. II Jun-06-2019
55 Zimmer Biomet, Inc. II Nov-30-2018
56 Zimmer Biomet, Inc. II Aug-18-2018
57 Zimmer Biomet, Inc. II Aug-17-2018
58 Zimmer Biomet, Inc. II Apr-20-2018
59 Zimmer Biomet, Inc. II Mar-28-2018
60 Zimmer Biomet, Inc. II Mar-06-2018
61 Zimmer Biomet, Inc. II Feb-27-2018
62 Zimmer Biomet, Inc. II Feb-07-2018
63 Zimmer Biomet, Inc. II Feb-04-2018
64 restor3d Inc. II Apr-29-2022
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