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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device screw, fixation, bone
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeHWC
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
  6
ADVANCED ORTHOPAEDIC SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  2
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 4
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 7
ARC SURGICAL LLC.
  SUBSTANTIALLY EQUIVALENT 3
ARTHREX, INC.
  1
  SUBSTANTIALLY EQUIVALENT 31
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 7
ARTHROTEK, INC.
  SUBSTANTIALLY EQUIVALENT 4
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOCOMPOSITES LTD.
  SUBSTANTIALLY EQUIVALENT 11
BIOMET
  4
  SUBSTANTIALLY EQUIVALENT 33
BIONX
  SUBSTANTIALLY EQUIVALENT 10
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 3
CAYENNE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
COAPT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 10
CONMED
  SUBSTANTIALLY EQUIVALENT 5
DEPUY INTL., LTD.
  4
  SUBSTANTIALLY EQUIVALENT 27
DJ ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 2
DOW
  SUBSTANTIALLY EQUIVALENT 2
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 8
GLOBUS
  SUBSTANTIALLY EQUIVALENT 2
HAYES
  1
IMPLEX
  SUBSTANTIALLY EQUIVALENT 1
INION
  SUBSTANTIALLY EQUIVALENT 11
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 4
KINETIKOS MEDICAL
  2
  SUBSTANTIALLY EQUIVALENT 5
KLS MARTIN GMBH and CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 3
LINVATEC
  3
  SUBSTANTIALLY EQUIVALENT 18
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MILLENNIUM
  SUBSTANTIALLY EQUIVALENT 2
MITEK
  SUBSTANTIALLY EQUIVALENT 9
MUSCULOSKELETAL TRANSPLANT FOUNDATION
  SUBSTANTIALLY EQUIVALENT 1
NEWDEAL
  SUBSTANTIALLY EQUIVALENT 9
NEXA ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 3
ONYX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
  10
OPUSMED INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOHELIX SURGICAL DESIGN
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPAEDIC BIOSYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC DESIGNS
  1
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 13
OSTEOTECH, INC.
  1
PARCUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 5
PIONEER
  1
  SUBSTANTIALLY EQUIVALENT 4
PLUS ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
REGENERATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
SCANDIUS BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 2
SMALL BONE INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 28
SPINAL CONCEPTS
  1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 15
SULZER
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  5
  SUBSTANTIALLY EQUIVALENT 26
T.A.G. MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
THEKEN SPINE
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 2
TREU-INSTRUMENTE GMBH
  SUBSTANTIALLY EQUIVALENT 1
TRIAGE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 5
U&I CORP.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 3
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 4
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 26
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 12

Device Problems
No Known Device Problem 1843
Break 1463
Unknown (for use when the device problem is not known) 440
Fracture 336
No Information 333
Migration of device or device component 275
Material fragmentation 268
Implant, removal of 233
Unintended movement 213
No code available 140
Loss of osseointegration 96
Device operates differently than expected 89
Loose or intermittent connection 70
Difficult to remove 60
Device Issue 53
Electro-magnetic interference (EMI) 52
Fitting problem 49
Device, or device fragments remain in patient 47
Dislodged or dislocated 46
Material twisted 44
Device remains implanted 43
Use of Device Issue 43
Difficult to insert 43
Improper or incorrect procedure or method 41
Malposition of device 40
Other (for use when an appropriate device code cannot be identified) 38
Bent 37
Component(s), broken 37
Material deformation 37
Corrosion 36
Loose 35
Detachment of device component 31
Failure to align 30
Malfunction 26
Detachment of device or device component 22
Explanted 22
Failure to Adhere or Bond 22
Displacement 22
Slippage of device or device component 20
Implant breakage or physical damage 20
Mechanical jam 20
Metal shedding debris 18
Component incompatible 17
Dull 17
Component missing 15
Mechanical issue 14
Not Applicable 13
Sticking 12
Noise, Audible 11
Device markings issue 11
Failure to separate 10
Peeled 10
Material frayed 10
Disengaged 10
Disassembly 9
Deployment issue 9
Implant, repositioning of 9
Patient-device incompatibility 8
Material integrity issue 8
Material separation 8
Difficult to position 7
Degraded 7
Size incorrect for patient 6
Tip breakage 6
Foreign material present in device 6
Packaging issue 6
Positioning Issue 6
Defective item 6
Component or accessory incompatibility 6
Failure to advance 5
Naturally worn 5
Extrusion 5
Difficult to advance 5
Device packaging compromised 5
Device inoperable 5
Failure to deploy 5
Device expiration issue 5
Failure to osseointegrate 4
Unstable 4
Suture line separation 4
Material Distortion 4
Material Protrusion 4
Failure to disconnect 4
Tear, rip or hole in device packaging 3
Out-of-box failure 3
Mechanics altered 3
Shelf life exceeded 3
Unraveled material 3
Unsealed device packaging 3
Material discolored 3
Unintended ejection 3
Foreign material 3
Crack 3
Material disintegration 3
Loss of or failure to bond 3
Dislocated 2
Entrapment of device or device component 2
Material erosion 2
Pitted 2
Mislabeled 2
Total Device Problems 7200

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 6 3 10 4 10 12 11 13 12 4
Class III 0 1 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II May-14-2010
2 Acumed LLC II Oct-23-2009
3 Acumed LLC II Sep-20-2008
4 Acumed LLC III Sep-11-2008
5 Acumed LLC II Aug-28-2008
6 ArthroCare Corporation II Oct-14-2011
7 Biomet Microfixation, Inc. II Jul-22-2011
8 Biomet Microfixation, Inc. II Jan-04-2010
9 Biomet, Inc. II May-26-2016
10 Biomet, Inc. II Jul-01-2015
11 Biomet, Inc. II Jan-30-2013
12 Biomet, Inc. II Mar-21-2012
13 Biomet, Inc. II Mar-09-2011
14 Biomet, Inc. II Feb-02-2010
15 Biomet, Inc. II Jan-13-2010
16 Biomet, Inc. II Nov-12-2009
17 DePuy Mitek, Inc., a Johnson & Johnson Co. II Jun-20-2017
18 DePuy Mitek, Inc., a Johnson & Johnson Co. II Oct-25-2012
19 Ebi, Llc II Nov-19-2013
20 Encore Medical, Lp II Oct-25-2012
21 Encore Medical, Lp II Aug-06-2012
22 Extremity Medical LLC II Jan-30-2013
23 Extremity Medical LLC II Nov-18-2012
24 Flower Orthopedics Corporation II Mar-24-2015
25 In2Bones, SAS II Dec-09-2015
26 In2Bones, SAS II Mar-25-2015
27 Innovatech Medical Resources L.P. II Jan-11-2012
28 Instratek, Incorporated II Sep-22-2014
29 Integra LifeSciences Corp. II Aug-19-2016
30 Integra LifeSciences Corp. II Aug-15-2008
31 Integra LifeSciences Corporation II Jun-02-2014
32 Integra LifeSciences Corporation II Apr-07-2010
33 Medartis, Inc. II Oct-30-2014
34 MicroAire Surgical Instruments, LLC II Jul-27-2016
35 Ortho Solutions Inc II Sep-16-2016
36 Ortho Solutions Inc II Oct-06-2015
37 OrthoPediatrics Corp II Sep-19-2016
38 OrthoPediatrics Corp II Feb-06-2014
39 OrthoPediatrics Corp II Aug-09-2013
40 OrthoPediatrics Corp II Jun-12-2013
41 Orthohelix Surgical Designs Inc II Oct-09-2012
42 Orthohelix Surgical Designs Inc II Jun-10-2010
43 Orthohelix Surgical Designs Inc II Apr-06-2010
44 Orthopedic Alliance LLC II May-24-2013
45 Pega Medical Inc. II Nov-20-2015
46 Pega Medical Inc. II Jun-26-2015
47 Small Bone Innovations II Jul-30-2014
48 Smith & Nephew, Inc. II Apr-18-2017
49 Smith & Nephew, Inc. Endoscopy Division II Sep-17-2013
50 Smith & Nephew, Inc. Endoscopy Division II Mar-19-2012
51 Smith & Nephew, Inc. Endoscopy Division II Mar-19-2008
52 Stryker Craniomaxillofacial Division II May-07-2010
53 Stryker Endoscopy II Dec-14-2010
54 Stryker Endoscopy II Aug-06-2008
55 Stryker Howmedica Osteonics Corp. II Apr-18-2016
56 Stryker Howmedica Osteonics Corp. II Dec-11-2013
57 Stryker Howmedica Osteonics Corp. II Aug-27-2013
58 Stryker Howmedica Osteonics Corp. II Nov-19-2012
59 Stryker Howmedica Osteonics Corp. III Sep-14-2009
60 Stryker Howmedica Osteonics Corp. II Sep-22-2008
61 Synthes (USA) Products LLC II Jul-11-2016
62 Synthes (USA) Products LLC II Apr-27-2016
63 Synthes (USA) Products LLC II Nov-20-2015
64 Synthes (USA) Products LLC II Sep-18-2015
65 Synthes USA HQ, Inc. II Nov-26-2013
66 Synthes USA HQ, Inc. II Oct-17-2013
67 Synthes USA HQ, Inc. II Mar-28-2013
68 Synthes, Inc. II Jun-15-2015
69 Synthes, Inc. II Aug-19-2014
70 Synthes, Inc. II Jul-02-2014
71 Trilliant Surgical LTD II Apr-26-2010
72 Trilliant Surgical Ltd. II Jan-06-2017
73 Trilliant Surgical Ltd. II Nov-17-2016
74 Trilliant Surgical Ltd. II Aug-26-2015
75 Trilliant Surgical Ltd. II Aug-19-2015
76 Wright Medical Technology Inc II Jun-17-2011
77 Wright Medical Technology, Inc. II May-18-2015
78 Zimmer Biomet, Inc. II Feb-16-2017
79 Zimmer Biomet, Inc. II Jan-13-2016
80 Zimmer Inc. II Jan-26-2009
81 Zimmer Manufacturing B.V. II May-16-2016
82 Zimmer Manufacturing B.V. II Mar-12-2016
83 Zimmer Manufacturing B.V. II Jul-10-2014
84 Zimmer, Inc. II Aug-26-2014
85 Zimmer, Inc. II Aug-16-2014
86 Zimmer, Inc. II Feb-20-2014
87 Zimmer, Inc. II Nov-06-2012

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