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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 4767 4772
2021 4833 4884
2022 4845 4913
2023 5183 5196
2024 4982 4982

Device Problems MDRs with this Device Problem Events in those MDRs
Break 11324 11324
Device-Device Incompatibility 4285 4285
Fracture 3112 3143
Material Deformation 1505 1543
Naturally Worn 1361 1361
Material Twisted/Bent 1359 1359
Detachment of Device or Device Component 1306 1306
Crack 957 957
Mechanical Jam 820 866
Scratched Material 616 616
Mechanical Problem 615 615
Physical Resistance/Sticking 603 603
Calibration Problem 577 577
Adverse Event Without Identified Device or Use Problem 447 449
Material Integrity Problem 410 410
Mechanics Altered 386 386
Material Fragmentation 382 382
Corroded 372 378
Contamination /Decontamination Problem 339 339
Use of Device Problem 244 244
Unintended Movement 238 238
Appropriate Term/Code Not Available 208 208
Difficult to Open or Close 207 207
Entrapment of Device 189 189
Loose or Intermittent Connection 173 173
Illegible Information 169 169
Compatibility Problem 167 167
Dull, Blunt 166 166
Difficult to Remove 164 164
Defective Device 160 160
Component Missing 153 153
No Apparent Adverse Event 147 147
Material Separation 137 137
Connection Problem 123 123
Insufficient Information 112 112
Degraded 103 103
Failure to Align 101 101
Material Discolored 97 97
Failure to Advance 96 96
Device Slipped 91 91
Material Split, Cut or Torn 84 84
Positioning Failure 78 78
Device Dislodged or Dislocated 68 68
Difficult to Advance 67 67
Device Contamination with Chemical or Other Material 63 63
Difficult to Insert 62 62
Unstable 59 59
Flaked 57 57
Manufacturing, Packaging or Shipping Problem 50 50
Fitting Problem 49 49

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17892 18024
No Consequences Or Impact To Patient 5513 5527
Insufficient Information 1780 1782
No Known Impact Or Consequence To Patient 1586 1586
Foreign Body In Patient 954 954
No Patient Involvement 766 766
No Code Available 594 594
Not Applicable 331 331
Device Embedded In Tissue or Plaque 278 278
No Information 160 160
Bone Fracture(s) 140 140
Failure of Implant 116 116
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 111 111
Injury 106 106
Pain 94 94
Unspecified Infection 73 73
Unspecified Tissue Injury 58 58
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
Spinal Column Injury 20 20
Hemorrhage/Bleeding 20 20
Perforation 18 18
Inflammation 17 17
Swelling/ Edema 16 16
Muscle/Tendon Damage 14 14
Limb Fracture 12 12
Subluxation 12 12
Ambulation Difficulties 12 12
Post Operative Wound Infection 11 11
Patient Problem/Medical Problem 11 11
Fluid Discharge 10 10
Rheumatoid Arthritis 10 10
Joint Laxity 9 9
Implant Pain 9 9
Blood Loss 9 9
Hypersensitivity/Allergic reaction 9 9
Bacterial Infection 8 8
Rupture 8 8
Discomfort 8 8
Burn(s) 8 8
Perforation of Vessels 7 7
Arthralgia 7 7
Hip Fracture 7 7
Hematoma 6 6
Scar Tissue 6 6
Numbness 6 6

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 Jun-18-2024
13 Howmedica Osteonics Corp. II Feb-06-2024
14 Howmedica Osteonics Corp. II Jun-14-2023
15 In2bones USA, LLC II Sep-22-2021
16 Intrinsic Therapeutics, Inc. II Aug-20-2024
17 K2M, Inc II Dec-07-2020
18 Laboratoires Bodycad, Inc. II Nov-17-2021
19 Medacta Usa Inc II Jun-07-2022
20 Medtronic Sofamor Danek USA Inc II May-10-2023
21 Mizuho OSI II Aug-24-2022
22 OMNIlife science Inc. II Feb-14-2019
23 ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL II Aug-29-2024
24 Pega Medical Inc. III May-15-2020
25 Pega Medical Inc. II Nov-01-2019
26 SONEX HEALTH LLC II Jul-15-2022
27 Smith & Nephew, Inc. II Aug-10-2020
28 Smith & Nephew, Inc. II Nov-08-2019
29 Smith & Nephew, Inc. II Jan-12-2019
30 Stryker Spine II Dec-21-2023
31 Synthes (USA) Products LLC II Feb-10-2022
32 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Jul-03-2023
33 TeDan Surgical Innovations LLC II Jul-10-2020
34 TeDan Surgical Innovations LLC II Mar-17-2020
35 Tornier, Inc II Jun-01-2022
36 TriMed Inc. II Nov-12-2019
37 Waldemar Link GmbH & Co. KG (Corp. Hq.) II Sep-24-2024
38 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-29-2023
39 Zimmer Biomet, Inc. II Jun-02-2020
40 Zimmer Biomet, Inc. II Jan-28-2020
41 Zimmer Biomet, Inc. II Dec-03-2019
42 Zimmer Biomet, Inc. II Nov-22-2019
43 Zimmer Biomet, Inc. II Nov-07-2019
44 Zimmer Biomet, Inc. II Jul-04-2019
45 Zimmer Biomet, Inc. II Jun-19-2019
46 Zimmer Biomet, Inc. II Jun-06-2019
47 restor3d Inc. II Apr-29-2022
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