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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 4845 4913
2023 5183 5196
2024 3534 3534

Device Problems MDRs with this Device Problem Events in those MDRs
Break 12688 12688
Device-Device Incompatibility 4248 4248
Fracture 3349 3380
Material Deformation 1593 1631
Naturally Worn 1538 1538
Material Twisted/Bent 1435 1435
Detachment of Device or Device Component 1350 1350
Crack 1230 1230
Mechanical Jam 934 980
Scratched Material 842 842
Mechanical Problem 670 670
Physical Resistance/Sticking 545 545
Calibration Problem 522 522
Adverse Event Without Identified Device or Use Problem 509 511
Appropriate Term/Code Not Available 425 425
Material Integrity Problem 408 408
Material Fragmentation 402 402
Corroded 379 385
Mechanics Altered 331 331
Contamination /Decontamination Problem 330 330
Difficult to Remove 250 250
Unintended Movement 232 232
Use of Device Problem 231 231
Loose or Intermittent Connection 227 227
Component Missing 225 225
Entrapment of Device 217 217
Dull, Blunt 201 201
Difficult to Open or Close 190 190
Defective Device 168 168
Illegible Information 162 162
Insufficient Information 160 160
Compatibility Problem 155 155
Connection Problem 150 150
Material Separation 148 148
Device Operates Differently Than Expected 136 136
No Apparent Adverse Event 136 136
Failure to Align 124 124
Device Contamination with Chemical or Other Material 117 117
Material Discolored 113 113
Degraded 105 105
Failure to Advance 104 104
Device Slipped 103 103
Material Split, Cut or Torn 92 92
Bent 89 89
Positioning Failure 88 88
Difficult to Insert 76 76
Device Dislodged or Dislocated 76 76
Difficult to Advance 66 66
Detachment Of Device Component 66 66
Separation Failure 63 63
Fitting Problem 62 62
Manufacturing, Packaging or Shipping Problem 58 58
Unstable 55 55
Flaked 55 55
Positioning Problem 53 53
Improper or Incorrect Procedure or Method 52 52
Device Markings/Labelling Problem 49 49
Device Damaged by Another Device 48 48
Device Damaged Prior to Use 48 48
Peeled/Delaminated 48 48
Deformation Due to Compressive Stress 42 53
Device Difficult to Setup or Prepare 37 37
Difficult or Delayed Separation 37 37
Material Disintegration 33 33
Solder Joint Fracture 32 32
Structural Problem 31 31
Patient Device Interaction Problem 31 31
Device Fell 30 30
Failure to Cut 30 30
Loosening of Implant Not Related to Bone-Ingrowth 29 29
Device Contaminated During Manufacture or Shipping 29 29
Incorrect Measurement 27 27
Metal Shedding Debris 26 26
Migration or Expulsion of Device 25 25
Activation, Positioning or Separation Problem 25 25
Separation Problem 24 24
Incomplete or Inadequate Connection 23 23
Defective Component 23 23
Residue After Decontamination 23 23
Display Difficult to Read 22 22
Difficult or Delayed Positioning 21 21
Migration 21 21
Inadequacy of Device Shape and/or Size 20 20
Problem with Sterilization 20 20
Device Issue 19 19
Failure to Disconnect 19 19
Delivered as Unsterile Product 19 19
Device Reprocessing Problem 18 18
Packaging Problem 18 18
Device Difficult to Maintain 18 18
Failure to Clean Adequately 18 18
Failure to Eject 17 43
Nonstandard Device 17 17
Off-Label Use 17 17
Output Problem 16 16
Device Handling Problem 15 15
Malposition of Device 15 15
Product Quality Problem 15 15
Patient-Device Incompatibility 14 14
Material Frayed 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16744 16876
No Consequences Or Impact To Patient 8274 8288
No Known Impact Or Consequence To Patient 2506 2506
Insufficient Information 1513 1515
Foreign Body In Patient 1031 1031
No Patient Involvement 1019 1019
No Code Available 814 814
Not Applicable 467 467
Device Embedded In Tissue or Plaque 368 368
No Information 364 364
Bone Fracture(s) 179 179
Injury 130 130
Failure of Implant 122 122
Pain 110 110
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 110 110
Unspecified Infection 89 89
Unspecified Tissue Injury 57 57
Tissue Damage 52 52
Loss of Range of Motion 31 31
Nerve Damage 27 27
Laceration(s) 25 25
Joint Dislocation 25 25
Non-union Bone Fracture 24 24
Spinal Column Injury 23 23
Hemorrhage/Bleeding 20 20
Perforation 19 19
Inflammation 17 17
Patient Problem/Medical Problem 15 15
Swelling/ Edema 15 15
Muscle/Tendon Damage 14 14
Pulmonary Embolism 14 14
Death 13 13
Post Operative Wound Infection 13 13
Blood Loss 12 12
Hip Fracture 12 12
Limb Fracture 12 12
Subluxation 11 11
Discomfort 10 10
Fluid Discharge 10 10
Rheumatoid Arthritis 10 10
Burn(s) 9 9
Ambulation Difficulties 9 9
Perforation of Vessels 9 9
Rupture 9 9
Joint Laxity 9 9
Implant Pain 8 8
Bacterial Infection 8 8
Foreign Body Reaction 8 8
Hypersensitivity/Allergic reaction 8 8
Paralysis 8 8
Hematoma 7 7
Weakness 7 7
Scar Tissue 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
Osteopenia/ Osteoporosis 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
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
Unspecified Musculoskeletal problem 3 3
Hyperextension 2 2
Skin Infection 2 2
Malunion of Bone 2 2
Paresthesia 2 2
External Prosthetic Device Pain 2 2
Physical Asymmetry 2 2
Unintended Radiation Exposure 2 2
Joint Disorder 2 2
Seroma 2 2
Synovitis 2 2
Thrombosis 2 2
Great Vessel Perforation 2 2
Neuralgia 2 2
Intraoperative Pain 2 2
Paraplegia 2 2
Quadriplegia 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 Jun-18-2024
18 Howmedica Osteonics Corp. II Feb-06-2024
19 Howmedica Osteonics Corp. II Jun-14-2023
20 Howmedica Osteonics Corp. II Dec-21-2018
21 Howmedica Osteonics Corp. II Nov-02-2018
22 Howmedica Osteonics Corp. II Oct-23-2018
23 Howmedica Osteonics Corp. II Mar-01-2018
24 In2bones USA, LLC II Sep-22-2021
25 K2M, Inc II Dec-07-2020
26 Laboratoires Bodycad, Inc. II Nov-17-2021
27 Medacta Usa Inc II Jun-07-2022
28 Medtronic Sofamor Danek USA Inc II May-10-2023
29 Mizuho OSI II Aug-24-2022
30 OMNIlife science Inc. II Feb-14-2019
31 Pega Medical Inc. III May-15-2020
32 Pega Medical Inc. II Nov-01-2019
33 SONEX HEALTH LLC II Jul-15-2022
34 Smith & Nephew, Inc. II Aug-10-2020
35 Smith & Nephew, Inc. II Nov-08-2019
36 Smith & Nephew, Inc. II Jan-12-2019
37 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
38 Stryker Spine II Dec-21-2023
39 Synthes (USA) Products LLC II Feb-10-2022
40 Synthes, Inc. II Apr-24-2018
41 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Jul-03-2023
42 TeDan Surgical Innovations LLC II Jul-10-2020
43 TeDan Surgical Innovations LLC II Mar-17-2020
44 Tornier, Inc II Jun-01-2022
45 TriMed Inc. II Nov-12-2019
46 TriMed Inc. II Apr-12-2018
47 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-29-2023
48 Zimmer Biomet, Inc. II Jun-02-2020
49 Zimmer Biomet, Inc. II Jan-28-2020
50 Zimmer Biomet, Inc. II Dec-03-2019
51 Zimmer Biomet, Inc. II Nov-22-2019
52 Zimmer Biomet, Inc. II Nov-07-2019
53 Zimmer Biomet, Inc. II Jul-04-2019
54 Zimmer Biomet, Inc. II Jun-19-2019
55 Zimmer Biomet, Inc. II Jun-06-2019
56 Zimmer Biomet, Inc. II Nov-30-2018
57 Zimmer Biomet, Inc. II Aug-18-2018
58 Zimmer Biomet, Inc. II Aug-17-2018
59 Zimmer Biomet, Inc. II Apr-20-2018
60 Zimmer Biomet, Inc. II Mar-28-2018
61 Zimmer Biomet, Inc. II Mar-06-2018
62 Zimmer Biomet, Inc. II Feb-27-2018
63 Zimmer Biomet, Inc. II Feb-07-2018
64 Zimmer Biomet, Inc. II Feb-04-2018
65 restor3d Inc. II Apr-29-2022
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