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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 3
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
AVANTA
  SUBSTANTIALLY EQUIVALENT 3
BIOMEDICAL ENTERPRISES
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 35
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 8
KOROS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 2
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 21
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 38
ZIMMER, INC.
  1
  SUBSTANTIALLY EQUIVALENT 29

Device Problems
Break 707
No Known Device Problem 629
Fracture 159
Implant, removal of 155
No Information 142
Unknown (for use when the device problem is not known) 116
Device operates differently than expected 86
Migration of device or device component 75
Component(s), broken 69
Fitting problem 67
No code available 59
Explanted 38
Bent 32
Loose or intermittent connection 29
Difficult to insert 27
Slippage of device or device component 26
Material fragmentation 26
Difficult to remove 24
Malfunction 24
Dislodged or dislocated 23
Other (for use when an appropriate device code cannot be identified) 21
Device markings issue 20
Malposition of device 20
Unintended movement 20
Failure to Adhere or Bond 16
Electro-magnetic interference (EMI) 16
Detachment of device or device component 15
Positioning Issue 13
Device remains implanted 13
Device Issue 12
Not Applicable 11
Dull 10
Detachment of device component 10
Corrosion 9
Loss of osseointegration 9
Component missing 9
Metal shedding debris 9
Mechanical issue 9
Material deformation 9
Connection issue 9
Use of Device Issue 8
Failure to align 8
Loose 8
Packaging issue 7
Mechanical jam 6
Mechanics altered 6
Material integrity issue 5
Sticking 5
Material rupture 5
Improper or incorrect procedure or method 4
Material discolored 4
Disengaged 4
Device-device incompatibility 4
Device or device component damaged by another device 4
Foreign material present in device 4
Patient-device incompatibility 4
Defective item 3
Device or device fragments location unknown 3
Locking mechanism failure 3
Incompatibility problem 3
Naturally worn 3
Device handling issue 3
Crack 3
Component falling 3
Size incorrect for patient 3
Tip breakage 3
Unraveled material 3
Device, or device fragments remain in patient 3
Replace 3
User used incorrect product for intended use 2
Unstable 2
Material separation 2
Implant, repositioning of 2
Internal fixation, revision of 2
Degraded 2
Incorrect measurement 2
Displacement 2
Osseointegration issue 2
Difficult to advance 2
Device, removal of (non-implant) 2
Failure to separate 2
Failure to cut 1
Implant breakage or physical damage 1
Buckled material 1
Failure to advance 1
Split 1
Structural problem 1
Material Distortion 1
Manufacturing or shipping issue associated with device 1
Device packaging compromised 1
Noise, Audible 1
Scratched material 1
Torn material 1
Drift 1
Misassembled 1
Nonstandard device or device component 1
Delivered as unsterile product 1
Overheating of device or device component 1
Unsealed device packaging 1
Peeled 1
Total Device Problems 2941

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

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