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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
2017 4132 4132
2018 4687 4687
2019 5224 5233
2020 4767 4772
2021 4845 4896
2022 3206 3252

Device Problems MDRs with this Device Problem Events in those MDRs
Break 11144 11144
Device-Device Incompatibility 2581 2581
Fracture 2521 2538
Crack 1260 1260
Material Twisted/Bent 1218 1218
Material Deformation 1193 1223
Naturally Worn 868 868
Scratched Material 841 841
Mechanical Jam 801 843
Mechanical Problem 660 660
Appropriate Term/Code Not Available 626 626
Detachment of Device or Device Component 499 499
Adverse Event Without Identified Device or Use Problem 433 435
Material Fragmentation 386 386
Calibration Problem 376 376
Material Integrity Problem 347 347
Device Operates Differently Than Expected 316 316
Corroded 289 289
Difficult to Remove 287 287
Component Missing 282 282
Loose or Intermittent Connection 255 255
Physical Resistance/Sticking 218 218
Insufficient Information 203 203
Bent 199 199
Mechanics Altered 198 198
Connection Problem 185 185
Entrapment of Device 184 184
Detachment Of Device Component 180 180
Contamination /Decontamination Problem 178 178
Illegible Information 148 148
Failure to Align 139 139
Dull, Blunt 137 137
Device Contamination with Chemical or Other Material 132 132
Unintended Movement 122 122
Use of Device Problem 122 122
Material Discolored 112 112
Compatibility Problem 109 109
Difficult to Open or Close 95 95
Fitting Problem 94 94
Defective Device 86 86
Material Separation 84 84
Difficult to Insert 81 81
Device Slipped 80 80
Degraded 78 78
Disassembly 77 77
Separation Failure 73 73
Positioning Failure 60 60
Device Dislodged or Dislocated 60 60
Positioning Problem 58 58
Device Damaged Prior to Use 50 50
Flaked 47 47
Failure to Advance 43 43
Peeled/Delaminated 42 42
Difficult to Advance 42 42
Deformation Due to Compressive Stress 42 53
Improper or Incorrect Procedure or Method 41 41
Material Disintegration 40 40
Metal Shedding Debris 40 40
No Apparent Adverse Event 39 39
Device Markings/Labelling Problem 38 38
Sticking 38 38
Device Damaged by Another Device 37 37
Residue After Decontamination 34 34
Material Split, Cut or Torn 33 33
Defective Component 33 33
Device Issue 31 31
Failure To Adhere Or Bond 29 29
Device Fell 29 29
Nonstandard Device 29 29
Solder Joint Fracture 28 28
Device Reprocessing Problem 27 27
Unstable 26 26
Difficult or Delayed Separation 24 24
Incomplete or Inadequate Connection 23 23
Migration or Expulsion of Device 23 23
Display Difficult to Read 22 22
Activation, Positioning or SeparationProblem 22 22
Failure to Cut 21 21
Failure to Disconnect 21 21
Difficult or Delayed Positioning 21 21
Device Difficult to Maintain 21 21
Inadequacy of Device Shape and/or Size 21 21
Device Inoperable 20 20
Packaging Problem 20 20
Device Difficult to Setup or Prepare 20 20
Structural Problem 19 19
Device Contaminated During Manufacture or Shipping 19 19
Migration 18 18
Device Handling Problem 18 18
Patient Device Interaction Problem 18 18
Manufacturing, Packaging or Shipping Problem 18 18
Component Falling 17 17
Separation Problem 17 17
Device Operational Issue 17 17
Patient-Device Incompatibility 16 16
Problem with Sterilization 16 16
Failure to Clean Adequately 16 16
Misconnection 16 16
Delivered as Unsterile Product 16 16
Failure to Eject 15 30

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 8925 8939
No Clinical Signs, Symptoms or Conditions 8013 8110
No Known Impact Or Consequence To Patient 4238 4238
No Information 1677 1677
No Patient Involvement 1230 1230
No Code Available 920 920
Foreign Body In Patient 782 782
Not Applicable 494 494
Insufficient Information 481 483
Device Embedded In Tissue or Plaque 473 473
Bone Fracture(s) 185 185
Injury 154 154
Failure of Implant 94 94
Pain 91 91
Unspecified Infection 80 80
Tissue Damage 58 58
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 48 48
Unspecified Tissue Injury 38 38
Loss of Range of Motion 21 21
Nerve Damage 17 17
Hemorrhage/Bleeding 17 17
Blood Loss 17 17
Patient Problem/Medical Problem 16 16
Hip Fracture 15 15
Non-union Bone Fracture 15 15
Inflammation 15 15
Pulmonary Embolism 14 14
Death 13 13
Laceration(s) 12 12
Discomfort 12 12
Joint Disorder 11 11
Joint Dislocation 10 10
Paralysis 10 10
Ambulation Difficulties 9 9
Post Operative Wound Infection 8 8
Weakness 7 7
Fluid Discharge 7 7
Perforation 7 7
Swelling 7 7
Scar Tissue 7 7
Spinal Column Injury 6 6
Foreign Body Reaction 6 6
Joint Laxity 6 6
Osteolysis 6 6
Reaction 6 6
Impaired Healing 5 5
Arthralgia 5 5
Implant Pain 5 5
Swelling/ Edema 5 5
Disc Impingement 5 5
Hematoma 5 5
Cardiac Arrest 5 5
Perforation of Vessels 5 5
Necrosis 5 5
Neurological Deficit/Dysfunction 5 5
Muscular Rigidity 4 4
Local Reaction 4 4
Synovitis 4 4
Arthritis 4 4
Burn(s) 4 4
Vessel Or Plaque, Device Embedded In 4 4
Inadequate Osseointegration 4 4
Limited Mobility Of The Implanted Joint 4 4
Limb Fracture 4 4
Rupture 4 4
Numbness 4 4
Spinal Cord Injury 4 4
Skin Irritation 3 3
Deformity/ Disfigurement 3 3
Nervous System Injury 3 3
Osteopenia/ Osteoporosis 3 3
Abscess 3 3
Adhesion(s) 3 3
Bacterial Infection 3 3
Fall 3 3
Myocardial Infarction 3 3
Damage to Ligament(s) 3 3
Irritation 3 3
Infiltration into Tissue 3 3
Itching Sensation 2 2
Hypersensitivity/Allergic reaction 2 2
Muscle Weakness 2 2
Neuropathy 2 2
Internal Organ Perforation 2 2
Overdose 2 2
Thrombosis 2 2
Rash 2 2
Exsanguination 2 2
Extravasation 2 2
Dysphagia/ Odynophagia 2 2
Cerebrospinal Fluid Leakage 2 2
Intraoperative Pain 2 2
Radiation Exposure, Unintended 2 2
Hyperextension 2 2
Subluxation 2 2
Malunion of Bone 2 2
Muscle/Tendon Damage 2 2
Unspecified Musculoskeletal problem 2 2
Physical Asymmetry 2 2
External Prosthetic Device Pain 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Mar-16-2017
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 Amendia, Inc II Apr-25-2017
7 Arthrex, Inc. II May-05-2022
8 Arthrex, Inc. II Jan-30-2020
9 Biomet II Jun-12-2020
10 Biomet U.K., Ltd. II Feb-22-2017
11 ConMed Corporation II Apr-27-2021
12 ConMed Corporation II Dec-21-2020
13 DePuy Mitek, Inc., a Johnson & Johnson Co. II Oct-23-2018
14 DePuy Mitek, Inc., a Johnson & Johnson Co. II May-08-2018
15 DePuy Orthopaedics, Inc. II Apr-11-2019
16 DePuy Orthopaedics, Inc. II Mar-02-2018
17 DePuy Orthopaedics, Inc. II Jun-08-2017
18 Encore Medical, Lp II Dec-06-2019
19 Exactech, Inc. II Oct-11-2018
20 Exactech, Inc. II Jun-19-2017
21 Exactech, Inc. II Jun-19-2017
22 Flower Orthopedics Corporation II Jan-28-2017
23 Greatbatch Medical II Feb-11-2017
24 Howmedica Osteonics Corp. II Dec-21-2018
25 Howmedica Osteonics Corp. II Nov-02-2018
26 Howmedica Osteonics Corp. II Oct-23-2018
27 Howmedica Osteonics Corp. II Mar-01-2018
28 Implant Direct Sybron Manufacturing, LLC II Sep-11-2017
29 In2bones USA, LLC II Sep-22-2021
30 K2M, Inc II Dec-07-2020
31 Laboratoires Bodycad, Inc. II Nov-17-2021
32 Limacorporate S.p.A II Nov-06-2017
33 MEDLINE INDUSTRIES INC II May-17-2017
34 Medacta Usa Inc II Jun-07-2022
35 Medtronic Sofamor Danek USA Inc II May-05-2017
36 Mizuho OSI II Aug-24-2022
37 OMNIlife science Inc. II Feb-14-2019
38 Pega Medical Inc. III May-15-2020
39 Pega Medical Inc. II Nov-01-2019
40 SONEX HEALTH LLC II Jul-15-2022
41 Smith & Nephew, Inc. II Aug-10-2020
42 Smith & Nephew, Inc. II Nov-08-2019
43 Smith & Nephew, Inc. II Jan-12-2019
44 Stryker Howmedica Osteonics Corp. II Jan-12-2017
45 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
46 Synthes (USA) Products LLC II Feb-10-2022
47 Synthes (USA) Products LLC II Feb-27-2017
48 Synthes, Inc. II Apr-24-2018
49 TeDan Surgical Innovations LLC II Jul-10-2020
50 TeDan Surgical Innovations LLC II Mar-17-2020
51 Tornier, Inc II Jun-01-2022
52 TriMed Inc. II Nov-12-2019
53 TriMed Inc. II Apr-12-2018
54 United Orthopedic Corporation II Mar-01-2017
55 Vertebral Technologies, Inc. II Feb-08-2017
56 Zimmer Biomet, Inc. II Jun-02-2020
57 Zimmer Biomet, Inc. II Jan-28-2020
58 Zimmer Biomet, Inc. II Dec-03-2019
59 Zimmer Biomet, Inc. II Nov-22-2019
60 Zimmer Biomet, Inc. II Nov-07-2019
61 Zimmer Biomet, Inc. II Jul-04-2019
62 Zimmer Biomet, Inc. II Jun-19-2019
63 Zimmer Biomet, Inc. II Jun-06-2019
64 Zimmer Biomet, Inc. II Nov-30-2018
65 Zimmer Biomet, Inc. II Aug-18-2018
66 Zimmer Biomet, Inc. II Aug-17-2018
67 Zimmer Biomet, Inc. II Apr-20-2018
68 Zimmer Biomet, Inc. II Mar-28-2018
69 Zimmer Biomet, Inc. II Mar-06-2018
70 Zimmer Biomet, Inc. II Feb-27-2018
71 Zimmer Biomet, Inc. II Feb-07-2018
72 Zimmer Biomet, Inc. II Feb-04-2018
73 Zimmer Biomet, Inc. II Apr-25-2017
74 restor3d Inc. II Apr-29-2022
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