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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device plate, fixation, bone
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeHRS
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 19
ADVANCED ORTHOPAEDIC SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 4
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 19
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 4
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
AVANTA
  SUBSTANTIALLY EQUIVALENT 3
BIOMEDICAL ENTERPRISES
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 39
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 2
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 22
DEROYAL
  SUBSTANTIALLY EQUIVALENT 2
DJ ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 6
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
HAND INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 6
I.T.S. GMBH
  SUBSTANTIALLY EQUIVALENT 3
INION
  SUBSTANTIALLY EQUIVALENT 3
INTEGRA
  SUBSTANTIALLY EQUIVALENT 4
KINAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
KINETIKOS MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 9
KOROS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 3
MACROPORE BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 2
MEDICON, E.G.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MONDEAL MEDICAL SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 3
NEWDEAL
  SUBSTANTIALLY EQUIVALENT 9
NEXA ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
ONYX MEDICAL CORP.
  14
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 4
ORTHOHELIX SURGICAL DESIGN
  SUBSTANTIALLY EQUIVALENT 17
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 11
PFIZER
  SUBSTANTIALLY EQUIVALENT 3
PIONEER
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 24
SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
SPINAL CONCEPTS
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  1
  SUBSTANTIALLY EQUIVALENT 46
SYNTHES
  1
  SUBSTANTIALLY EQUIVALENT 96
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 2
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 6
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 40
ZIMMER, INC.
  1
  SUBSTANTIALLY EQUIVALENT 29

Device Problems
No Known Device Problem 1041
Break 1009
Fracture 261
No Information 184
Migration of device or device component 168
Implant, removal of 155
Unknown (for use when the device problem is not known) 116
Device operates differently than expected 114
Fitting problem 108
No code available 71
Component(s), broken 69
Material fragmentation 62
Unintended movement 54
Difficult to insert 43
Bent 41
Explanted 38
Loose or intermittent connection 37
Difficult to remove 30
Slippage of device or device component 28
Dislodged or dislocated 27
Malfunction 24
Component missing 24
Dull 24
Device markings issue 23
Malposition of device 22
Other (for use when an appropriate device code cannot be identified) 21
Material deformation 19
Detachment of device or device component 17
Metal shedding debris 16
Failure to Adhere or Bond 16
Electro-magnetic interference (EMI) 16
Failure to align 15
Device-device incompatibility 15
Not Applicable 14
Positioning Issue 14
Corrosion 13
Detachment of device component 13
Device Issue 13
Device remains implanted 13
Failure to osseointegrate 12
Mechanical issue 12
Loss of osseointegration 10
Patient-device incompatibility 10
Connection issue 9
Packaging issue 9
Device inoperable 8
Use of Device Issue 8
Loose 8
Foreign material present in device 7
Mechanical jam 7
Mechanics altered 7
Component or accessory incompatibility 6
Crack 5
Material discolored 5
Sticking 5
Material rupture 5
Material separation 5
Improper or incorrect procedure or method 4
Disengaged 4
Disassembly 4
Failure to separate 4
Device or device fragments location unknown 4
Material integrity issue 4
Device or device component damaged by another device 4
Incompatibility problem 3
Material Distortion 3
Naturally worn 3
Locking mechanism failure 3
Defective item 3
Device handling issue 3
Component falling 3
Incorrect measurement 3
Size incorrect for patient 3
Tip breakage 3
Unraveled material 3
Device, or device fragments remain in patient 3
Replace 3
Peeled 3
Difficult to position 3
User used incorrect product for intended use 3
Unstable 2
Internal fixation, revision of 2
Implant, repositioning of 2
Device expiration issue 2
Unsealed device packaging 2
Delivered as unsterile product 2
Misassembled 2
Misconnection 2
Displacement 2
Device, removal of (non-implant) 2
Osseointegration issue 2
Manufacturing or shipping issue associated with device 2
Extrusion 2
Difficult to advance 2
Difficult to open or remove packaging material 1
Device packaging compromised 1
Failure to cut 1
Failure to advance 1
Split 1
Structural problem 1
Total Device Problems 4236

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 2 3 5 5 5 9 9 10 12 8 2
Class III 1 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 ACUTE Innovations, LLC II Jan-28-2014
2 Acumed LLC II Feb-14-2017
3 Acumed LLC II Apr-25-2014
4 Acumed LLC II Jun-16-2010
5 Acumed LLC III Aug-28-2008
6 Acute Innovations Llc II Dec-01-2011
7 Arthrex, Inc. II Apr-08-2016
8 Biomet Microfixation, Inc. II Jan-24-2012
9 Biomet Microfixation, Inc. II May-27-2009
10 Biomet, Inc. II May-26-2016
11 Biomet, Inc. II Dec-18-2015
12 Biomet, Inc. II Jul-10-2015
13 Biomet, Inc. II Jul-08-2015
14 Biomet, Inc. II Aug-13-2014
15 Biomet, Inc. II Jan-10-2014
16 Biomet, Inc. II Apr-19-2012
17 Depuy Orthopaedics, Inc. II Mar-07-2011
18 Depuy Orthopaedics, Inc. II Feb-11-2009
19 In2Bones, SAS II Jan-06-2017
20 Integra LifeSciences Corp II Dec-01-2008
21 Integra LifeSciences Corp. II Jun-14-2016
22 Integra LifeSciences Corp. II Aug-01-2012
23 Integra LifeSciences Corp. II Mar-02-2012
24 Integra LifeSciences Corp. II Jan-25-2011
25 OrthoHelix Surgical Designs Inc II Dec-19-2007
26 OrthoHelix Surgical Designs Inc III Jan-19-2007
27 OrthoPediatrics Corp II Sep-18-2015
28 OrthoPediatrics Corp II Nov-14-2013
29 OrthoPediatrics Corp II Nov-22-2012
30 OrthoPediatrics Corp II Jul-20-2012
31 Orthohelix Surgical Designs Inc II Jan-11-2012
32 Orthohelix Surgical Designs Inc II Aug-29-2011
33 Smith & Nephew Inc II Aug-31-2010
34 Smith & Nephew, Inc. II Dec-04-2015
35 Stryker Howmedica Osteonics Corp. II Feb-16-2011
36 Stryker Howmedica Osteonics Corp. II Apr-13-2009
37 Stryker Howmedica Osteonics Corp. II Mar-25-2008
38 Synthes II Jan-11-2007
39 Synthes (USA) Products LLC II Aug-11-2016
40 Synthes (USA) Products LLC II Jun-10-2016
41 Synthes (USA) Products LLC II Nov-06-2015
42 Synthes (USA) Products LLC II Oct-30-2015
43 Synthes (USA) Products LLC II Oct-15-2015
44 Synthes (USA) Products LLC II Nov-27-2013
45 Synthes (USA) Products LLC II Aug-26-2013
46 Synthes Spine II Jun-01-2009
47 Synthes Spine II May-21-2009
48 Synthes USA (HQ), Inc. II Nov-02-2010
49 Synthes USA (HQ), Inc. II Feb-24-2010
50 Synthes USA HQ, Inc. II Nov-22-2013
51 Synthes USA HQ, Inc. II Aug-26-2013
52 Synthes USA HQ, Inc. II Jun-19-2013
53 Synthes USA HQ, Inc. II Mar-15-2013
54 Synthes, Inc. II Mar-25-2014
55 Synthes, Inc. II Mar-11-2014
56 Trilliant Surgical Ltd. II Sep-04-2015
57 Trilliant Surgical Ltd. II Aug-31-2015
58 Trimed Inc II Sep-20-2016
59 Wright Medical Technology Inc II Aug-09-2010
60 Wright Medical Technology, Inc. II Sep-01-2015
61 Wright Medical Technology, Inc. II Apr-22-2015
62 Wright Medical Technology, Inc. II Sep-08-2014
63 Zimmer Biomet, Inc. II Jan-14-2016
64 Zimmer Inc. II Sep-11-2008
65 Zimmer Manufacturing B.V. II Mar-12-2016
66 Zimmer, Inc. II Aug-26-2014
67 Zimmer, Inc. II Jul-30-2014
68 Zimmer, Inc. II Feb-20-2014
69 Zimmer, Inc. II Dec-27-2013
70 Zimmer, Inc. II Aug-27-2013
71 Zimmer, Inc. II Nov-06-2012
72 Zimmer, Inc. II Aug-10-2012

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