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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 6
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 2
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 944
Break 799
Unknown (for use when the device problem is not known) 440
Implant, removal of 233
Fracture 212
No Information 196
Migration of device or device component 165
Material fragmentation 140
No code available 94
Unintended movement 83
Loss of osseointegration 69
Device Issue 52
Device operates differently than expected 51
Electro-magnetic interference (EMI) 51
Device, or device fragments remain in patient 47
Device remains implanted 43
Difficult to insert 41
Use of Device Issue 40
Other (for use when an appropriate device code cannot be identified) 38
Fitting problem 37
Component(s), broken 37
Loose 35
Improper or incorrect procedure or method 31
Malposition of device 31
Difficult to remove 29
Detachment of device component 29
Loose or intermittent connection 29
Dislodged or dislocated 28
Malfunction 26
Displacement 22
Explanted 21
Implant breakage or physical damage 20
Detachment of device or device component 20
Component incompatible 17
Bent 17
Corrosion 15
Slippage of device or device component 14
Material deformation 14
Not Applicable 13
Failure to align 13
Metal shedding debris 13
Failure to Adhere or Bond 13
Disengaged 10
Disassembly 9
Implant, repositioning of 9
Material frayed 8
Component missing 8
Mechanical issue 8
Peeled 8
Material separation 7
Dull 7
Deployment issue 7
Material integrity issue 6
Mechanical jam 6
Tip breakage 6
Sticking 6
Size incorrect for patient 5
Failure to deploy 5
Device markings issue 5
Positioning Issue 5
Defective item 5
Failure to disconnect 4
Failure to separate 4
Extrusion 4
Foreign material present in device 4
Material Protrusion 4
Suture line separation 4
Device inoperable 3
Unraveled material 3
Material disintegration 3
Loss of or failure to bond 3
Foreign material 3
Device expiration issue 3
Mechanics altered 3
Material Distortion 3
Device packaging compromised 3
Patient-device incompatibility 3
Tear, rip or hole in device packaging 3
Incompatibility problem 2
Manufacturing or shipping issue associated with device 2
Naturally worn 2
Packaging issue 2
Entrapment of device or device component 2
Mislabeled 2
Dislocated 2
Crack 2
Failure to osseointegrate 2
Device damaged prior to use 2
Unexpected therapeutic results 2
Pitted 2
Difficult to position 2
Unsealed device packaging 2
Particulates 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
Total Device Problems 4485

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 9
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-19-2016
29 Integra LifeSciences Corp. II Aug-15-2008
30 Integra LifeSciences Corporation II Jun-02-2014
31 Integra LifeSciences Corporation II Apr-07-2010
32 Medartis, Inc. II Oct-30-2014
33 MicroAire Surgical Instruments, LLC II Jul-27-2016
34 Ortho Solutions Inc II Oct-06-2015
35 OrthoPediatrics Corp II Feb-06-2014
36 OrthoPediatrics Corp II Aug-09-2013
37 OrthoPediatrics Corp II Jun-12-2013
38 Orthohelix Surgical Designs Inc II Oct-09-2012
39 Orthohelix Surgical Designs Inc II Jun-10-2010
40 Orthohelix Surgical Designs Inc II Apr-06-2010
41 Orthopedic Alliance LLC II May-24-2013
42 Pega Medical Inc. II Nov-20-2015
43 Pega Medical Inc. II Jun-26-2015
44 Small Bone Innovations II Jul-30-2014
45 Smith & Nephew, Inc. Endoscopy Division II Sep-17-2013
46 Smith & Nephew, Inc. Endoscopy Division II Mar-19-2012
47 Smith & Nephew, Inc. Endoscopy Division II Mar-19-2008
48 Stryker Craniomaxillofacial Division II May-07-2010
49 Stryker Endoscopy II Dec-14-2010
50 Stryker Endoscopy II Aug-06-2008
51 Stryker Howmedica Osteonics Corp. II Apr-18-2016
52 Stryker Howmedica Osteonics Corp. II Dec-11-2013
53 Stryker Howmedica Osteonics Corp. II Aug-27-2013
54 Stryker Howmedica Osteonics Corp. II Nov-19-2012
55 Stryker Howmedica Osteonics Corp. III Sep-14-2009
56 Stryker Howmedica Osteonics Corp. II Sep-22-2008
57 Synthes (USA) Products LLC II Jul-11-2016
58 Synthes (USA) Products LLC II Apr-27-2016
59 Synthes (USA) Products LLC II Nov-20-2015
60 Synthes (USA) Products LLC II Sep-18-2015
61 Synthes USA HQ, Inc. II Nov-26-2013
62 Synthes USA HQ, Inc. II Oct-17-2013
63 Synthes USA HQ, Inc. II Mar-28-2013
64 Synthes, Inc. II Jun-15-2015
65 Synthes, Inc. II Aug-19-2014
66 Synthes, Inc. II Jul-02-2014
67 Trilliant Surgical LTD II Apr-26-2010
68 Trilliant Surgical Ltd. II Aug-26-2015
69 Trilliant Surgical Ltd. II Aug-19-2015
70 Wright Medical Technology Inc II Jun-17-2011
71 Wright Medical Technology, Inc. II May-18-2015
72 Zimmer Biomet, Inc. II Jan-13-2016
73 Zimmer Inc. II Jan-26-2009
74 Zimmer Manufacturing B.V. II May-16-2016
75 Zimmer Manufacturing B.V. II Mar-12-2016
76 Zimmer Manufacturing B.V. II Jul-10-2014
77 Zimmer, Inc. II Aug-26-2014
78 Zimmer, Inc. II Aug-16-2014
79 Zimmer, Inc. II Feb-20-2014
80 Zimmer, Inc. II Nov-06-2012

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