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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 30
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 5
ARTHROTEK, INC.
  SUBSTANTIALLY EQUIVALENT 4
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 5
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
HAYES
  1
IMPLEX
  SUBSTANTIALLY EQUIVALENT 1
INION
  SUBSTANTIALLY EQUIVALENT 11
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 4
KINETIKOS MEDICAL
  2
  SUBSTANTIALLY EQUIVALENT 5
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC
  3
  SUBSTANTIALLY EQUIVALENT 18
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
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 24
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 12

Device Problems
No Known Device Problem 848
Break 744
Unknown (for use when the device problem is not known) 440
Implant, removal of 233
Fracture 199
No Information 176
Migration of device or device component 127
Material fragmentation 125
No code available 90
Unintended movement 70
Loss of osseointegration 63
Device Issue 52
Electro-magnetic interference (EMI) 51
Device, or device fragments remain in patient 47
Device remains implanted 43
Use of Device Issue 40
Difficult to insert 38
Other (for use when an appropriate device code cannot be identified) 38
Device operates differently than expected 38
Component(s), broken 37
Loose 35
Fitting problem 34
Improper or incorrect procedure or method 31
Difficult to remove 29
Malposition of device 29
Detachment of device component 28
Loose or intermittent connection 28
Malfunction 26
Dislodged or dislocated 25
Displacement 22
Explanted 21
Implant breakage or physical damage 20
Component incompatible 17
Bent 15
Slippage of device or device component 14
Metal shedding debris 13
Material deformation 12
Failure to align 11
Failure to Adhere or Bond 11
Corrosion 10
Disengaged 10
Detachment of device or device component 10
Implant, repositioning of 9
Not Applicable 9
Disassembly 8
Material frayed 8
Component missing 8
Mechanical issue 8
Material separation 7
Dull 7
Deployment issue 6
Mechanical jam 6
Sticking 6
Tip breakage 6
Size incorrect for patient 5
Failure to deploy 5
Material integrity issue 5
Positioning Issue 5
Defective item 5
Failure to separate 4
Extrusion 4
Foreign material present in device 4
Material Protrusion 4
Device markings issue 4
Peeled 4
Suture line separation 4
Unraveled material 3
Material disintegration 3
Loss of or failure to bond 3
Foreign material 3
Device expiration issue 3
Material Distortion 3
Mechanics altered 3
Failure to disconnect 3
Device packaging compromised 3
Tear, rip or hole in device packaging 3
Patient-device incompatibility 2
Incompatibility problem 2
Naturally worn 2
Manufacturing or shipping issue associated with device 2
Packaging issue 2
Entrapment of device or device component 2
Mislabeled 2
Dislocated 2
Crack 2
Unexpected therapeutic results 2
Device inoperable 2
Device damaged prior to use 2
Failure to osseointegrate 2
Unsealed device packaging 2
Particulates 1
Difficult to position 1
User used incorrect product for intended use 1
Rejection 1
Shelf life exceeded 1
Replace 1
Incorrect or inadequate result 1
Seal, defective 1
Incomplete or missing packaging 1
Tears, rips, holes in device, device material 1
Total Device Problems 4159

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 6 3 10 4 10 12 11 13 6
Class III 0 1 1 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 Oct-25-2012
18 Ebi, Llc II Nov-19-2013
19 Encore Medical, Lp II Oct-25-2012
20 Encore Medical, Lp II Aug-06-2012
21 Extremity Medical LLC II Jan-30-2013
22 Extremity Medical LLC II Nov-18-2012
23 Flower Orthopedics Corporation II Mar-24-2015
24 In2Bones, SAS II Dec-09-2015
25 In2Bones, SAS II Mar-25-2015
26 Innovatech Medical Resources L.P. II Jan-11-2012
27 Instratek, Incorporated II Sep-22-2014
28 Integra LifeSciences Corp. II Aug-15-2008
29 Integra LifeSciences Corporation II Jun-02-2014
30 Integra LifeSciences Corporation II Apr-07-2010
31 Medartis, Inc. II Oct-30-2014
32 Ortho Solutions Inc II Oct-06-2015
33 OrthoPediatrics Corp II Feb-06-2014
34 OrthoPediatrics Corp II Aug-09-2013
35 OrthoPediatrics Corp II Jun-12-2013
36 Orthohelix Surgical Designs Inc II Oct-09-2012
37 Orthohelix Surgical Designs Inc II Jun-10-2010
38 Orthohelix Surgical Designs Inc II Apr-06-2010
39 Orthopedic Alliance LLC II May-24-2013
40 Pega Medical Inc. II Nov-20-2015
41 Pega Medical Inc. II Jun-26-2015
42 Small Bone Innovations II Jul-30-2014
43 Smith & Nephew, Inc. Endoscopy Division II Sep-17-2013
44 Smith & Nephew, Inc. Endoscopy Division II Mar-19-2012
45 Smith & Nephew, Inc. Endoscopy Division II Mar-19-2008
46 Stryker Craniomaxillofacial Division II May-07-2010
47 Stryker Endoscopy II Dec-14-2010
48 Stryker Endoscopy II Aug-06-2008
49 Stryker Howmedica Osteonics Corp. II Apr-18-2016
50 Stryker Howmedica Osteonics Corp. II Dec-11-2013
51 Stryker Howmedica Osteonics Corp. II Aug-27-2013
52 Stryker Howmedica Osteonics Corp. II Nov-19-2012
53 Stryker Howmedica Osteonics Corp. III Sep-14-2009
54 Stryker Howmedica Osteonics Corp. II Sep-22-2008
55 Synthes (USA) Products LLC II Apr-27-2016
56 Synthes (USA) Products LLC II Nov-20-2015
57 Synthes (USA) Products LLC II Sep-18-2015
58 Synthes USA HQ, Inc. II Nov-26-2013
59 Synthes USA HQ, Inc. II Oct-17-2013
60 Synthes USA HQ, Inc. II Mar-28-2013
61 Synthes, Inc. II Jun-15-2015
62 Synthes, Inc. II Aug-19-2014
63 Synthes, Inc. II Jul-02-2014
64 Trilliant Surgical LTD II Apr-26-2010
65 Trilliant Surgical Ltd. II Aug-26-2015
66 Trilliant Surgical Ltd. II Aug-19-2015
67 Wright Medical Technology Inc II Jun-17-2011
68 Wright Medical Technology, Inc. II May-18-2015
69 Zimmer Biomet, Inc. II Jan-13-2016
70 Zimmer Inc. II Jan-26-2009
71 Zimmer Manufacturing B.V. II May-16-2016
72 Zimmer Manufacturing B.V. II Mar-12-2016
73 Zimmer Manufacturing B.V. II Jul-10-2014
74 Zimmer, Inc. II Aug-26-2014
75 Zimmer, Inc. II Aug-16-2014
76 Zimmer, Inc. II Feb-20-2014
77 Zimmer, Inc. II Nov-06-2012

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