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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
KOROS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOVITA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SONEX HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3843 3843
2015 5947 5947
2016 6360 6360
2017 4132 4132
2018 4685 4685
2019 5224 5233
2020 4767 4772
2021 4833 4884
2022 4845 4913
2023 5183 5196
2024 4438 4438

Device Problems MDRs with this Device Problem Events in those MDRs
Break 24329 24329
Fracture 4743 4774
Device-Device Incompatibility 4427 4427
Appropriate Term/Code Not Available 2220 2220
Crack 1916 1916
Material Deformation 1807 1845
Naturally Worn 1754 1754
Detachment of Device or Device Component 1603 1603
Material Twisted/Bent 1473 1473
Mechanical Jam 1363 1409
Mechanical Problem 938 938
Material Integrity Problem 891 891
Device Operates Differently Than Expected 890 890
Scratched Material 872 872
Material Fragmentation 727 727
Adverse Event Without Identified Device or Use Problem 694 696
Detachment Of Device Component 656 656
Corroded 656 662
Dull, Blunt 644 644
Component Missing 598 598
Physical Resistance/Sticking 594 594
Calibration Problem 577 577
Difficult to Remove 525 525
Insufficient Information 520 520
Bent 482 482
Mechanics Altered 415 415
Contamination /Decontamination Problem 358 358
Loose or Intermittent Connection 350 350
Failure to Align 337 337
Fitting Problem 327 327
Use of Device Problem 304 304
Entrapment of Device 261 261
Unintended Movement 256 256
Connection Problem 234 234
Difficult to Open or Close 223 223
Material Separation 212 212
Sticking 202 202
Defective Device 201 201
Device Slipped 193 193
Device Contamination with Chemical or Other Material 192 192
Tip breakage 179 179
Illegible Information 179 179
Compatibility Problem 169 169
No Apparent Adverse Event 166 166
Disassembly 163 163
Material Discolored 163 163
Degraded 158 158
Difficult to Insert 158 158
Failure to Advance 150 150
Device Dislodged or Dislocated 146 146

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17446 17578
No Known Impact Or Consequence To Patient 11193 11193
No Consequences Or Impact To Patient 10271 10286
No Information 7540 7540
No Patient Involvement 1835 1835
Insufficient Information 1680 1682
Foreign Body In Patient 1412 1412
No Code Available 1401 1401
Device Embedded In Tissue or Plaque 1091 1091
Not Applicable 505 505
Bone Fracture(s) 327 327
Injury 224 224
Pain 170 170
Unspecified Infection 168 168
Sedation 154 154
Failure of Implant 149 149
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 111 111
Tissue Damage 89 89
Unspecified Tissue Injury 58 58
Unknown (for use when the patient's condition is not known) 56 56
Laceration(s) 36 36
Loss of Range of Motion 33 33
Non-union Bone Fracture 32 32
Blood Loss 32 32
Joint Dislocation 31 31
Hemorrhage/Bleeding 31 31
Nerve Damage 28 28
Spinal Column Injury 25 25
Perforation 24 24
Ambulation Difficulties 20 20
Discomfort 20 20
Hip Fracture 20 20
Inflammation 19 19
Death 19 19
Patient Problem/Medical Problem 17 17
Perforation of Vessels 16 16
Swelling/ Edema 16 16
Post Operative Wound Infection 16 16
Paralysis 16 16
Bacterial Infection 14 14
Foreign Body Reaction 14 14
Pulmonary Embolism 14 14
Muscle/Tendon Damage 14 14
Complaint, Ill-Defined 13 13
Swelling 13 13
Burn(s) 13 13
Limb Fracture 12 12
Joint Disorder 12 12
Subluxation 12 12
Hematoma 12 12

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Dec-26-2023
2 Acumed LLC II Mar-16-2017
3 Ad-Tech Medical Instrument Corporation II May-25-2018
4 Aesculap Implant Systems LLC II Jul-21-2022
5 Aesculap Implant Systems LLC II Jul-21-2022
6 Aesculap Implant Systems LLC II Jul-15-2022
7 Aesculap, Inc. II Nov-19-2013
8 Aesculap, Inc. II Oct-18-2012
9 Amendia, Inc II Apr-25-2017
10 Amendia, Inc II Dec-22-2016
11 Arthrex, Inc. II May-05-2022
12 Arthrex, Inc. II Jan-30-2020
13 ArthroCare Medical Corporation II Jan-09-2014
14 Bacterin International, Inc. II Apr-07-2015
15 Biomet II Jun-12-2020
16 Biomet Microfixation, Inc. II Aug-01-2011
17 Biomet Microfixation, Inc. II Nov-10-2009
18 Biomet U.K., Ltd. II Feb-22-2017
19 Biomet U.K., Ltd. II Mar-19-2012
20 Biomet, Inc. II May-26-2016
21 Biomet, Inc. II Feb-25-2016
22 Biomet, Inc. II Jun-16-2014
23 Biomet, Inc. II Mar-20-2014
24 Biomet, Inc. II Jun-15-2013
25 Biomet, Inc. II Mar-08-2013
26 Biomet, Inc. II Sep-30-2011
27 Biomet, Inc. II Jun-30-2011
28 Biomet, Inc. II Dec-28-2010
29 Biomet, Inc. II Sep-28-2010
30 Biomet, Inc. II Sep-25-2010
31 Biomet, Inc. II Jan-15-2010
32 Biomet, Inc. II Jun-01-2009
33 Biomet, Inc. II Jan-07-2009
34 Captiva Spine, Inc II Apr-21-2015
35 Cardinal Health 200, LLC II Oct-11-2016
36 ConMed Corporation II Apr-27-2021
37 ConMed Corporation II Dec-21-2020
38 DePuy Mitek, Inc., a Johnson & Johnson Co. II Oct-23-2018
39 DePuy Mitek, Inc., a Johnson & Johnson Co. II May-08-2018
40 DePuy Mitek, Inc., a Johnson & Johnson Co. II Aug-31-2011
41 DePuy Orthopaedics, Inc. II Apr-11-2019
42 DePuy Orthopaedics, Inc. II Mar-02-2018
43 DePuy Orthopaedics, Inc. II Jun-08-2017
44 DePuy Orthopaedics, Inc. II Oct-07-2015
45 DePuy Orthopaedics, Inc. II Mar-31-2015
46 DePuy Orthopaedics, Inc. II Jan-12-2015
47 DePuy Orthopaedics, Inc. II Jan-05-2015
48 DePuy Orthopaedics, Inc. II Jan-05-2015
49 DePuy Orthopaedics, Inc. II Nov-10-2014
50 DePuy Orthopaedics, Inc. II Oct-08-2014
51 DePuy Orthopaedics, Inc. II Nov-27-2013
52 DePuy Orthopaedics, Inc. II Mar-19-2013
53 DePuy Orthopaedics, Inc. II Apr-16-2012
54 DePuy Orthopaedics, Inc. II Apr-16-2012
55 Depuy Orthopaedics, Inc. II Mar-22-2011
56 Depuy Orthopaedics, Inc. II Feb-22-2011
57 Depuy Orthopaedics, Inc. II Oct-06-2010
58 Ebi, Llc II Sep-17-2013
59 Encore Medical, Lp II Dec-06-2019
60 Encore Medical, Lp II Nov-02-2011
61 Encore Medical, Lp II Sep-30-2010
62 Encore Medical, Lp II Aug-02-2010
63 Exactech, Inc. II Oct-11-2018
64 Exactech, Inc. II Jun-19-2017
65 Exactech, Inc. II Jun-19-2017
66 Flower Orthopedics Corporation II Jan-28-2017
67 Greatbatch Medical II Feb-11-2017
68 Greatbatch Medical II Jan-30-2013
69 Howmedica Osteonics Corp. II Jun-18-2024
70 Howmedica Osteonics Corp. II Feb-06-2024
71 Howmedica Osteonics Corp. II Jun-14-2023
72 Howmedica Osteonics Corp. II Dec-21-2018
73 Howmedica Osteonics Corp. II Nov-02-2018
74 Howmedica Osteonics Corp. II Oct-23-2018
75 Howmedica Osteonics Corp. II Mar-01-2018
76 Implant Direct Sybron Manufacturing, LLC II Sep-11-2017
77 In2bones USA, LLC II Sep-22-2021
78 Integra LifeSciences Corp. II Jan-23-2009
79 Intrinsic Therapeutics, Inc. II Aug-20-2024
80 K2M, Inc II Dec-07-2020
81 LDR Spine USA, Inc. II Oct-05-2016
82 Laboratoires Bodycad, Inc. II Nov-17-2021
83 Limacorporate S.p.A II Nov-06-2017
84 Limacorporate S.p.A II Aug-31-2016
85 Linvatec Corp. dba ConMed Linvatec II Feb-05-2013
86 Linvatec Corp. dba ConMed Linvatec II Oct-29-2012
87 Linvatec Corp. dba ConMed Linvatec II Aug-06-2012
88 Linvatec Corp. dba ConMed Linvatec II Aug-06-2012
89 Linvatec Corp. dba ConMed Linvatec II Aug-24-2010
90 MEDLINE INDUSTRIES INC II May-17-2017
91 Medacta Usa Inc II Jun-07-2022
92 Medtronic Sofamor Danek USA Inc II May-10-2023
93 Medtronic Sofamor Danek USA Inc II May-05-2017
94 Medtronic Sofamor Danek USA Inc II Apr-19-2012
95 Medtronic Sofamor Danek USA Inc II Jan-12-2010
96 Microport Orthopedics INC. II Jun-04-2014
97 Mizuho OSI II Aug-24-2022
98 OMNIlife science Inc. II Feb-14-2019
99 ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL II Aug-29-2024
100 Orthohelix Surgical Designs Inc II Oct-10-2014
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