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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
2021 4832 4897
2022 4844 4951
2023 5163 5229
2024 6319 6344
2025 6197 6337

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10261 10323
Device-Device Incompatibility 4079 4095
Fracture 3233 3305
Material Deformation 1909 1953
Detachment of Device or Device Component 1237 1241
Naturally Worn 1172 1177
Mechanics Altered 961 961
Material Twisted/Bent 758 760
Physical Resistance/Sticking 670 670
Mechanical Jam 656 697
Crack 601 606
Calibration Problem 469 470
Mechanical Problem 452 452
Material Integrity Problem 416 417
Contamination /Decontamination Problem 382 388
Material Fragmentation 330 420
Adverse Event Without Identified Device or Use Problem 316 356
Use of Device Problem 308 312
Difficult to Open or Close 274 274
Corroded 267 275
Unintended Movement 239 239
No Apparent Adverse Event 221 221
Compatibility Problem 166 166
Entrapment of Device 145 146
Defective Device 140 141
Appropriate Term/Code Not Available 135 135
Optical Problem 126 126
Dull, Blunt 124 124
Material Separation 112 112
Scratched Material 105 105
Degraded 103 103
Failure to Advance 94 94
Material Split, Cut or Torn 92 92
Failure to Align 87 88
Loose or Intermittent Connection 86 87
Positioning Failure 86 86
Device Slipped 82 82
Difficult to Advance 73 73
Difficult to Remove 70 70
Insufficient Information 67 69
Connection Problem 60 60
Unstable 60 60
Difficult to Insert 59 59
Illegible Information 58 58
Manufacturing, Packaging or Shipping Problem 55 55
Device Damaged by Another Device 54 54
Flaked 53 53
Improper or Incorrect Procedure or Method 51 51
Device Dislodged or Dislocated 46 51
Device Difficult to Setup or Prepare 44 45

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23424 23762
Insufficient Information 2526 2541
Foreign Body In Patient 980 988
Device Embedded In Tissue or Plaque 112 112
Failure of Implant 106 109
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 103 104
Bone Fracture(s) 81 84
Pain 80 87
Unspecified Tissue Injury 53 53
Unspecified Infection 46 75
Laceration(s) 29 31
Perforation 28 30
Spinal Column Injury 26 26
Loss of Range of Motion 24 28
No Consequences Or Impact To Patient 22 22
Nerve Damage 20 20
Swelling/ Edema 19 19
Hemorrhage/Bleeding 18 18
Implant Pain 16 16
Muscle/Tendon Damage 16 19
Non-union Bone Fracture 15 18
Limb Fracture 14 14
Joint Dislocation 13 16
Ambulation Difficulties 12 12
Post Operative Wound Infection 9 9
Perforation of Vessels 9 9
Hypersensitivity/Allergic reaction 9 9
Bacterial Infection 8 8
Numbness 7 7
No Known Impact Or Consequence To Patient 7 7
Osteopenia/ Osteoporosis 7 7
Necrosis 6 6
Scar Tissue 6 6
Joint Laxity 6 7
Rupture 6 8
Foreign Body Reaction 6 6
No Information 5 5
Fluid Discharge 5 5
Discomfort 5 5
Inflammation 5 5
Cerebrospinal Fluid Leakage 5 5
Burn(s) 5 5
Impaired Healing 5 5
No Patient Involvement 4 4
Osteolysis 4 4
Spinal Cord Injury 4 4
Cardiac Arrest 4 4
Arthralgia 4 4
Abrasion 4 4
Unspecified Musculoskeletal problem 4 4

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 ConMed Corporation II Apr-27-2021
7 DePuy Mitek, Inc., a Johnson & Johnson Co. II Mar-11-2025
8 Gauthier Biomedical, Inc. II Nov-27-2024
9 Howmedica Osteonics Corp. II Jun-18-2024
10 Howmedica Osteonics Corp. II Feb-06-2024
11 Howmedica Osteonics Corp. II Jun-14-2023
12 In2bones USA, LLC II Sep-22-2021
13 Integrity Implants Inc. II Jan-22-2025
14 Intrinsic Therapeutics, Inc. II Aug-20-2024
15 Laboratoires Bodycad, Inc. II Nov-17-2021
16 Medacta Usa Inc II Jun-07-2022
17 Medtronic Sofamor Danek USA Inc II May-10-2023
18 Mizuho OSI II Aug-24-2022
19 ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL II Aug-29-2024
20 SONEX HEALTH LLC II Jul-15-2022
21 Spineology, Inc. II Oct-17-2024
22 Stryker GmbH II Apr-17-2025
23 Stryker Spine II Dec-21-2023
24 Synthes (USA) Products LLC II Feb-10-2022
25 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Jul-03-2023
26 Tornier, Inc II Jun-01-2022
27 Waldemar Link GmbH & Co. KG (Corp. Hq.) II Sep-24-2024
28 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-29-2023
29 restor3d Inc. II Apr-29-2022
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