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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 4765 4772
2021 4832 4897
2022 4843 4950
2023 5163 5229
2024 6319 6344
2025 6198 6338
2026 3315 3316

Device Problems MDRs with this Device Problem Events in those MDRs
Break 12335 12396
Device-Device Incompatibility 5252 5268
Fracture 4026 4098
Material Deformation 2497 2541
Detachment of Device or Device Component 1397 1401
Naturally Worn 1265 1270
Material Twisted/Bent 1230 1232
Mechanics Altered 1189 1189
Mechanical Jam 886 932
Crack 791 796
Physical Resistance/Sticking 752 752
Mechanical Problem 638 638
Calibration Problem 614 615
Material Fragmentation 582 672
Material Integrity Problem 517 518
Contamination /Decontamination Problem 475 481
Adverse Event Without Identified Device or Use Problem 407 448
Use of Device Problem 364 366
Scratched Material 329 329
Difficult to Open or Close 308 308
Corroded 288 296
Unintended Movement 277 277
No Apparent Adverse Event 266 266
Compatibility Problem 196 196
Dull, Blunt 190 190
Defective Device 178 178
Illegible Information 176 176
Appropriate Device Problem Term/Code Not Available 158 158
Failure to Align 152 153
Optical Problem 144 144
Material Separation 137 137
Degraded 128 128
Positioning Failure 120 120
Entrapment of Device 118 119
Loose or Intermittent Connection 115 116
Failure to Advance 105 105
Device Slipped 100 100
Insufficient Device Problem Information 95 97
Material Split, Cut or Torn 93 93
Component Missing 86 86
Connection Problem 83 83
Unstable 80 80
Difficult to Advance 78 78
Difficult to Insert 69 69
Device Damaged by Another Device 63 63
Device Dislodged or Dislocated 59 62
Difficult to Remove 59 59
Manufacturing, Packaging or Shipping Problem 57 57
Flaked 55 55
Device Difficult to Setup or Prepare 53 54

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27410 27751
Insufficient Information 2673 2688
No Consequences Or Impact To Patient 2328 2334
Foreign Body In Patient 1217 1225
No Known Impact Or Consequence To Patient 752 753
No Patient Involvement 429 429
No Code Available 366 366
Device Embedded In Tissue or Plaque 202 202
Failure of Implant 125 128
Bone Fracture(s) 124 127
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 119 120
Not Applicable 102 102
Pain 99 106
Injury 77 77
Unspecified Tissue Injury 70 70
Unspecified Infection 54 83
No Information 50 50
Perforation 39 41
Hemorrhage/Blood Loss/Bleeding 33 33
Laceration(s) 32 34
Spinal Column Injury 27 27
Nerve Damage 25 25
Loss of Range of Motion 24 28
Limb Fracture 21 21
Swelling/ Edema 19 19
Muscle/Tendon Damage 17 20
Nonunion/Delayed-union Bone Fracture 16 19
Implant Pain 16 16
Joint Dislocation 15 18
Perforation of Vessels 15 15
Tissue Damage 14 14
Ambulation or Postural Difficulties 12 12
Fluid Discharge 10 10
Numbness 9 9
Post Operative Wound Infection 9 9
Foreign Body Reaction 9 9
Joint Laxity 9 10
Bacterial Infection 9 9
Hypersensitivity/Allergic reaction 9 9
Arthralgia 8 8
Hematoma 8 10
Osteopenia/ Osteoporosis 8 8
Burn(s) 8 8
Patient Problem/Medical Problem 8 8
Inflammation 7 7
Discomfort 7 7
Impaired Healing 7 7
Cerebrospinal Fluid Leakage 6 6
Necrosis 6 6
Spinal Cord Injury 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 Biomet, Inc. II Aug-03-2026
9 ConMed Corporation II Apr-27-2021
10 ConMed Corporation II Dec-21-2020
11 DePuy Mitek, Inc., a Johnson & Johnson Co. II Mar-11-2025
12 Gauthier Biomedical, Inc. II Nov-27-2024
13 Howmedica Osteonics Corp. II Jun-18-2024
14 Howmedica Osteonics Corp. II Feb-06-2024
15 Howmedica Osteonics Corp. II Jun-14-2023
16 In2bones USA, LLC II Sep-22-2021
17 Integrity Implants Inc. II Jan-22-2025
18 Intrinsic Therapeutics, Inc. II Aug-20-2024
19 K2M, Inc II Dec-07-2020
20 Laboratoires Bodycad, Inc. II Nov-17-2021
21 Medacta Usa Inc II Jun-07-2022
22 Medtronic Sofamor Danek USA Inc II May-10-2023
23 Mizuho OSI II Aug-24-2022
24 ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL II Aug-29-2024
25 Pega Medical Inc. III May-15-2020
26 SONEX HEALTH LLC II Jul-15-2022
27 Smith & Nephew, Inc. II Aug-10-2020
28 Spineology, Inc. II Oct-17-2024
29 Stryker GmbH II Apr-17-2025
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 United Orthopedic Corp. II Aug-06-2026
37 United Orthopedic Corp. II Aug-05-2026
38 Waldemar Link GmbH & Co. KG (Corp. Hq.) II Sep-24-2024
39 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-29-2023
40 Zimmer Biomet, Inc. II Jun-02-2020
41 Zimmer Biomet, Inc. II Jan-28-2020
42 restor3d Inc. II Apr-29-2022
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