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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 4833 4884
2022 4845 4913
2023 5182 5195
2024 6328 6328
2025 1159 1159

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10380 10380
Device-Device Incompatibility 4048 4048
Fracture 2992 3023
Material Deformation 1528 1566
Detachment of Device or Device Component 1240 1240
Naturally Worn 1235 1235
Material Twisted/Bent 1014 1014
Mechanical Jam 699 736
Crack 650 650
Mechanics Altered 579 579
Physical Resistance/Sticking 563 563
Calibration Problem 517 517
Mechanical Problem 492 492
Material Integrity Problem 408 408
Adverse Event Without Identified Device or Use Problem 341 343
Contamination /Decontamination Problem 327 327
Scratched Material 307 307
Material Fragmentation 306 306
Use of Device Problem 248 248
Corroded 227 233
Difficult to Open or Close 220 220
Unintended Movement 210 210
No Apparent Adverse Event 171 171
Compatibility Problem 171 171
Defective Device 168 168
Entrapment of Device 165 165
Appropriate Term/Code Not Available 163 163
Illegible Information 160 160
Dull, Blunt 157 157
Material Separation 128 128
Loose or Intermittent Connection 120 120
Degraded 109 109
Difficult to Remove 100 100
Failure to Align 95 95
Component Missing 93 93
Failure to Advance 87 87
Connection Problem 86 86
Material Split, Cut or Torn 78 78
Device Slipped 77 77
Positioning Failure 75 75
Insufficient Information 73 73
Difficult to Advance 67 67
Unstable 58 58
Flaked 56 56
Device Dislodged or Dislocated 50 50
Manufacturing, Packaging or Shipping Problem 50 50
Difficult to Insert 48 48
Improper or Incorrect Procedure or Method 45 45
Device Damaged by Another Device 38 38
Difficult or Delayed Separation 38 38

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19907 20039
No Consequences Or Impact To Patient 2328 2333
Insufficient Information 2215 2217
Foreign Body In Patient 919 919
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 168 168
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 115 115
Not Applicable 103 103
Bone Fracture(s) 103 103
Failure of Implant 102 102
Injury 77 77
Pain 71 71
Unspecified Tissue Injury 61 61
Unspecified Infection 50 50
No Information 50 50
Laceration(s) 29 29
Joint Dislocation 25 25
Nerve Damage 23 23
Hemorrhage/Bleeding 22 22
Loss of Range of Motion 22 22
Perforation 22 22
Spinal Column Injury 20 20
Swelling/ Edema 16 16
Muscle/Tendon Damage 16 16
Tissue Damage 14 14
Non-union Bone Fracture 13 13
Limb Fracture 13 13
Subluxation 12 12
Ambulation Difficulties 10 10
Rheumatoid Arthritis 10 10
Fluid Discharge 10 10
Joint Laxity 9 9
Post Operative Wound Infection 9 9
Implant Pain 9 9
Hypersensitivity/Allergic reaction 9 9
Numbness 8 8
Arthralgia 8 8
Perforation of Vessels 8 8
Burn(s) 8 8
Patient Problem/Medical Problem 8 8
Inflammation 7 7
Bacterial Infection 7 7
Hematoma 6 6
Scar Tissue 6 6
Rupture 6 6
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 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 Spine II Dec-21-2023
29 Synthes (USA) Products LLC II Feb-10-2022
30 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Jul-03-2023
31 TeDan Surgical Innovations LLC II Jul-10-2020
32 TeDan Surgical Innovations LLC II Mar-17-2020
33 Tornier, Inc II Jun-01-2022
34 Waldemar Link GmbH & Co. KG (Corp. Hq.) II Sep-24-2024
35 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-29-2023
36 Zimmer Biomet, Inc. II Jun-02-2020
37 Zimmer Biomet, Inc. II Jan-28-2020
38 restor3d Inc. II Apr-29-2022
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