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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 36
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 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 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 807
No Known Device Problem 743
Fracture 190
No Information 158
Implant, removal of 155
Unknown (for use when the device problem is not known) 116
Device operates differently than expected 101
Migration of device or device component 96
Fitting problem 82
Component(s), broken 69
No code available 68
Bent 38
Explanted 38
Material fragmentation 35
Unintended movement 34
Difficult to insert 33
Loose or intermittent connection 32
Slippage of device or device component 26
Dislodged or dislocated 25
Malfunction 24
Difficult to remove 24
Malposition of device 22
Device markings issue 21
Other (for use when an appropriate device code cannot be identified) 21
Detachment of device or device component 17
Material deformation 16
Dull 16
Failure to Adhere or Bond 16
Electro-magnetic interference (EMI) 16
Positioning Issue 14
Device remains implanted 13
Device Issue 12
Metal shedding debris 11
Not Applicable 11
Detachment of device component 10
Mechanical issue 10
Corrosion 9
Loss of osseointegration 9
Component missing 9
Connection issue 9
Failure to align 8
Use of Device Issue 8
Loose 8
Device-device incompatibility 7
Packaging issue 7
Material integrity issue 6
Mechanical jam 6
Mechanics altered 6
Patient-device incompatibility 6
Foreign material present in device 5
Sticking 5
Material rupture 5
Improper or incorrect procedure or method 4
Material discolored 4
Disengaged 4
Device or device component damaged by another device 4
Incompatibility problem 3
Naturally worn 3
Failure to separate 3
Defective item 3
Device or device fragments location unknown 3
Locking mechanism failure 3
Device handling issue 3
Crack 3
Component falling 3
Material separation 3
Size incorrect for patient 3
Replace 3
Device, or device fragments remain in patient 3
Tip breakage 3
Unraveled material 3
Unstable 2
User used incorrect product for intended use 2
Failure to osseointegrate 2
Implant, repositioning of 2
Internal fixation, revision of 2
Degraded 2
Displacement 2
Incorrect measurement 2
Device expiration issue 2
Peeled 2
Device, removal of (non-implant) 2
Osseointegration issue 2
Difficult to advance 2
Device packaging compromised 1
Manufacturing or shipping issue associated with device 1
Material Distortion 1
Failure to advance 1
Split 1
Structural problem 1
Failure to cut 1
Implant breakage or physical damage 1
Buckled material 1
Noise, Audible 1
Scratched material 1
Torn material 1
Difficult to position 1
Device Difficult to Setup or Prepare 1
Device abrasion from instrument or another object 1
Misassembled 1
Total Device Problems 3336

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

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