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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
Regulation Description Orthopedic manual surgical instrument.
Product CodeLXH
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 4766 4771
2021 4832 4883
2022 4844 4915
2023 5163 5178
2024 6319 6319
2025 5098 5150

Device Problems MDRs with this Device Problem Events in those MDRs
Break 11670 11699
Device-Device Incompatibility 4611 4611
Fracture 3486 3517
Material Deformation 1996 2034
Detachment of Device or Device Component 1332 1332
Naturally Worn 1264 1264
Material Twisted/Bent 1135 1135
Mechanics Altered 965 965
Mechanical Jam 790 827
Crack 724 724
Physical Resistance/Sticking 697 697
Mechanical Problem 547 547
Calibration Problem 547 547
Material Integrity Problem 473 473
Contamination /Decontamination Problem 410 410
Adverse Event Without Identified Device or Use Problem 388 416
Material Fragmentation 361 361
Use of Device Problem 321 323
Scratched Material 319 319
Corroded 285 291
Difficult to Open or Close 273 273
Unintended Movement 239 239
No Apparent Adverse Event 218 218
Defective Device 186 186
Compatibility Problem 185 185
Entrapment of Device 173 173
Appropriate Term/Code Not Available 168 168
Dull, Blunt 163 163
Illegible Information 161 161
Material Separation 133 133
Loose or Intermittent Connection 125 125
Failure to Align 120 120
Degraded 119 119
Optical Problem 119 119
Difficult to Remove 104 104
Component Missing 96 96
Positioning Failure 95 95
Failure to Advance 92 92
Device Slipped 91 91
Material Split, Cut or Torn 90 90
Connection Problem 87 87
Insufficient Information 83 83
Difficult to Advance 76 76
Unstable 71 71
Difficult to Insert 61 61
Flaked 57 57
Device Damaged by Another Device 57 57
Manufacturing, Packaging or Shipping Problem 57 57
Device Dislodged or Dislocated 52 54
Improper or Incorrect Procedure or Method 51 51

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23347 23505
Insufficient Information 2542 2544
No Consequences Or Impact To Patient 2328 2333
Foreign Body In Patient 1041 1044
No Known Impact Or Consequence To Patient 752 752
No Patient Involvement 429 429
No Code Available 367 367
Device Embedded In Tissue or Plaque 179 179
Failure of Implant 121 121
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 117 117
Bone Fracture(s) 114 114
Not Applicable 103 103
Pain 92 94
Injury 77 77
Unspecified Tissue Injury 70 70
Unspecified Infection 51 77
No Information 50 50
Laceration(s) 30 32
Hemorrhage/Bleeding 27 27
Spinal Column Injury 26 26
Perforation 26 26
Loss of Range of Motion 24 24
Nerve Damage 24 24
Swelling/ Edema 19 19
Muscle/Tendon Damage 16 16
Non-union Bone Fracture 15 15
Implant Pain 15 15
Joint Dislocation 15 15
Tissue Damage 14 14
Limb Fracture 13 13
Ambulation Difficulties 12 12
Perforation of Vessels 10 10
Fluid Discharge 10 10
Bacterial Infection 9 9
Joint Laxity 9 9
Numbness 9 9
Hypersensitivity/Allergic reaction 9 9
Post Operative Wound Infection 9 9
Patient Problem/Medical Problem 8 8
Burn(s) 8 8
Arthralgia 8 8
Inflammation 7 7
Spinal Cord Injury 6 6
Cerebrospinal Fluid Leakage 6 6
Scar Tissue 6 6
Discomfort 6 6
Foreign Body Reaction 6 6
Necrosis 6 6
Rupture 6 6
Hematoma 6 8

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 Mitek, Inc., a Johnson & Johnson Co. II Mar-11-2025
11 Gauthier Biomedical, Inc. II Nov-27-2024
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 Integrity Implants Inc. II Jan-22-2025
17 Intrinsic Therapeutics, Inc. II Aug-20-2024
18 K2M, Inc II Dec-07-2020
19 Laboratoires Bodycad, Inc. II Nov-17-2021
20 Medacta Usa Inc II Jun-07-2022
21 Medtronic Sofamor Danek USA Inc II May-10-2023
22 Mizuho OSI II Aug-24-2022
23 ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL II Aug-29-2024
24 Pega Medical Inc. III May-15-2020
25 SONEX HEALTH LLC II Jul-15-2022
26 Smith & Nephew, Inc. II Aug-10-2020
27 Spineology, Inc. II Oct-17-2024
28 Stryker GmbH II Apr-17-2025
29 Stryker Spine II Dec-21-2023
30 Synthes (USA) Products LLC II Feb-10-2022
31 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Jul-03-2023
32 TeDan Surgical Innovations LLC II Jul-10-2020
33 TeDan Surgical Innovations LLC II Mar-17-2020
34 Tornier, Inc II Jun-01-2022
35 Waldemar Link GmbH & Co. KG (Corp. Hq.) II Sep-24-2024
36 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-29-2023
37 Zimmer Biomet, Inc. II Jun-02-2020
38 Zimmer Biomet, Inc. II Jan-28-2020
39 restor3d Inc. II Apr-29-2022
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