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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device rod, fixation, intramedullary and accessories
Regulation Description Intramedullary fixation rod.
Product CodeHSB
Regulation Number 888.3020
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 11
ADVANCED ORTHOPAEDIC SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 13
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 1
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 16
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 17
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 4
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 6
I.T.S. GMBH
  SUBSTANTIALLY EQUIVALENT 1
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEWDEAL
  SUBSTANTIALLY EQUIVALENT 1
ONYX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 6
PFIZER
  SUBSTANTIALLY EQUIVALENT 1
PIONEER
  SUBSTANTIALLY EQUIVALENT 1
PLUS ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
SMALL BONE INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 8
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 47
SURGICAL IMPLANT GENERATION NETWORK (SIGN)
  SUBSTANTIALLY EQUIVALENT 3
SYNTHES
  SUBSTANTIALLY EQUIVALENT 23
TORNIER
  SUBSTANTIALLY EQUIVALENT 2
U&I CORP.
  SUBSTANTIALLY EQUIVALENT 3
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 6
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 15

Device Problems
No Known Device Problem 767
Break 693
Migration of device or device component 268
Fracture 265
Implant, removal of 197
Device operates differently than expected 174
Fitting problem 134
Failure to align 124
No Information 99
Unintended movement 89
Mechanical jam 64
No code available 63
Displacement 63
Component(s), broken 60
Device handling issue 54
Difficult to insert 48
Device remains implanted 36
Unknown (for use when the device problem is not known) 35
Device packaging compromised 35
Difficult to remove 32
Other (for use when an appropriate device code cannot be identified) 28
Sticking 24
Material fragmentation 24
Bent 24
Nonstandard device or device component 23
Malposition of device 22
Material deformation 16
Failure to Adhere or Bond 16
Detachment of device component 14
Malfunction 14
Tear, rip or hole in device packaging 12
Size incorrect for patient 12
Explanted 11
Device markings issue 11
Failure to advance 11
Loose or intermittent connection 10
Dislodged 8
Loss of or failure to bond 8
Difficult to position 8
Improper or incorrect procedure or method 8
Detachment of device or device component 8
Difficult to advance 8
Positioning Issue 7
Material integrity issue 7
Use of Device Issue 7
Mechanical issue 6
Crack 6
Disengaged 6
Noise, Audible 6
Corrosion 5
Disassembly 5
Delivered as unsterile product 5
Metal shedding debris 5
Component missing 5
Loose 4
Device expiration issue 4
Dislodged or dislocated 4
Foreign material present in device 4
Incompatibility problem 4
Device or device component damaged by another device 4
Implant breakage or physical damage 4
Device-device incompatibility 3
Mechanics altered 3
Foreign material 3
Unsealed device packaging 3
Failure to deploy 3
Collapse 3
Device Issue 3
Unstable 3
Slippage of device or device component 2
Tip breakage 2
Device inoperable 2
User used incorrect product for intended use 2
Shelf life exceeded 2
Device, or device fragments remain in patient 2
Dull 2
Failure to disconnect 2
Failure to separate 2
Component incompatible 2
Material discolored 2
Accessory incompatible 2
Material Protrusion 2
Material Distortion 2
Packaging issue 2
Deployment issue 2
Patient-device incompatibility 1
Dent in material 1
Implant Mobility NOS (Not otherwise specified) 1
Difficult to open or close 1
Therapeutic or diagnostic output failure 1
Osseointegration issue 1
Misassembled by Users 1
Component falling 1
Device Cleaning Issue 1
Peeled 1
Unintended collision 1
Hole in material 1
Entrapment of device or device component 1
Material erosion 1
Defective item 1
Total Device Problems 3789

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 1 0 0 0 0 0 0 0 0
Class II 0 2 5 8 2 8 10 7 12 7 1
Class III 0 0 3 0 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Apr-02-2012
2 Acumed LLC II May-10-2010
3 Advanced Orthopaedic Solutions Inc II Mar-22-2010
4 Biomet, Inc. II May-26-2016
5 Biomet, Inc. II Apr-30-2012
6 CarboFix Orthopedics, Ltd. II Jun-14-2016
7 EBI, L.P. III Sep-22-2009
8 EBI, L.P. III Sep-21-2009
9 Hospira Inc II Oct-06-2009
10 Integra LifeSciences Corp. II Mar-23-2017
11 Integra LifeSciences Corp. II Apr-16-2012
12 Integra LifeSciences Corp. II Sep-16-2008
13 Integra LifeSciences Corporation II Jul-16-2013
14 Integra LifeSciences Corporation II Nov-02-2010
15 Medacta Usa II Nov-12-2014
16 OrthoPediatrics Corp III Dec-22-2016
17 OrthoPediatrics Corp II Nov-05-2012
18 Orthofix, Inc II Feb-28-2013
19 Orthofix, Inc II Nov-13-2009
20 Orthopediatrics Corp II May-12-2010
21 Pega Medical Inc. II Apr-29-2015
22 Pega Medical Inc. II Apr-02-2015
23 Pega Medical Inc. II Apr-18-2014
24 Pega Medical Inc. II Apr-10-2014
25 Pega Medical Inc. II Mar-02-2011
26 Smith & Nephew Inc II Apr-17-2013
27 Smith & Nephew Inc II Sep-16-2008
28 Stryker Howmedica Osteonics Corp. II Sep-13-2016
29 Stryker Howmedica Osteonics Corp. II Feb-25-2016
30 Stryker Howmedica Osteonics Corp. II Oct-14-2014
31 Stryker Howmedica Osteonics Corp. II Jan-28-2014
32 Stryker Howmedica Osteonics Corp. II Jul-31-2013
33 Stryker Howmedica Osteonics Corp. II Jul-16-2012
34 Stryker Howmedica Osteonics Corp. II Nov-09-2010
35 Stryker Howmedica Osteonics Corp. II Sep-02-2010
36 Stryker Howmedica Osteonics Corp. II Feb-24-2010
37 Stryker Howmedica Osteonics Corp. III Aug-18-2009
38 Stryker Spine II Nov-08-2011
39 Synthes (USA) Products LLC II Nov-19-2016
40 Synthes (USA) Products LLC II Dec-04-2015
41 Synthes (USA) Products LLC II Oct-15-2015
42 Synthes (USA) Products LLC II Jul-16-2015
43 Synthes USA (HQ), Inc. I Nov-09-2009
44 Synthes USA HQ, Inc. II Dec-10-2013
45 Synthes USA HQ, Inc. II Dec-05-2013
46 Synthes USA HQ, Inc. II Nov-25-2013
47 Synthes USA HQ, Inc. II Nov-20-2013
48 Synthes USA HQ, Inc. II Aug-26-2013
49 Synthes USA HQ, Inc. II Jul-23-2012
50 Synthes, Inc. II Jun-26-2015
51 Synthes, Inc. II May-12-2015
52 Synthes, Inc. II Mar-30-2015
53 Synthes, Inc. II Nov-14-2014
54 Tornier, Inc II Jul-29-2015
55 Vilex In Tennessee Inc II Jun-08-2015
56 Wright Medical Technology Inc II May-02-2012
57 Zimmer Gmbh II Oct-14-2015
58 Zimmer Inc. II Dec-28-2010
59 Zimmer Inc. II Nov-24-2009
60 Zimmer Inc. II Aug-04-2009
61 Zimmer Inc. II May-18-2009
62 Zimmer Manufacturing B.V. II May-16-2016
63 Zimmer Manufacturing B.V. II Mar-12-2016
64 Zimmer, Inc. II Jul-13-2015
65 Zimmer, Inc. II Feb-20-2014
66 Zimmer, Inc. II Dec-27-2013
67 Zimmer, Inc. II Nov-06-2012

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