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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 5
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
Break 576
No Known Device Problem 569
Fracture 226
Migration of device or device component 202
Implant, removal of 197
Device operates differently than expected 137
Failure to align 101
Fitting problem 96
No Information 81
Unintended movement 66
Displacement 63
Component(s), broken 60
No code available 56
Device handling issue 54
Mechanical jam 49
Difficult to insert 38
Device remains implanted 36
Unknown (for use when the device problem is not known) 35
Device packaging compromised 32
Other (for use when an appropriate device code cannot be identified) 28
Difficult to remove 28
Sticking 25
Nonstandard device or device component 23
Material fragmentation 22
Bent 21
Malposition of device 20
Malfunction 14
Detachment of device component 13
Size incorrect for patient 12
Material deformation 12
Loose or intermittent connection 11
Explanted 11
Failure to Adhere or Bond 10
Tear, rip or hole in device packaging 10
Device markings issue 10
Detachment of device or device component 8
Improper or incorrect procedure or method 8
Loss of or failure to bond 8
Dislodged 8
Use of Device Issue 7
Failure to advance 7
Difficult to advance 7
Material integrity issue 7
Noise, Audible 6
Difficult to position 6
Disengaged 6
Corrosion 5
Crack 5
Delivered as unsterile product 5
Mechanical issue 5
Metal shedding debris 5
Positioning Issue 5
Dislodged or dislocated 4
Foreign material present in device 4
Incompatibility problem 4
Implant breakage or physical damage 4
Loose 4
Foreign material 3
Device expiration issue 3
Unsealed device packaging 3
Failure to deploy 3
Disassembly 3
Collapse 3
Unstable 3
Component missing 3
Failure to separate 3
Mechanics altered 3
Material Protrusion 2
Packaging issue 2
Deployment issue 2
Device or device component damaged by another device 2
Material Distortion 2
Device-device incompatibility 2
Failure to disconnect 2
Device Issue 2
Slippage of device or device component 2
Tip breakage 2
Device inoperable 2
Shelf life exceeded 2
Device, or device fragments remain in patient 2
Component incompatible 2
Material discolored 2
Accessory incompatible 2
Component falling 1
Device Cleaning Issue 1
Peeled 1
Unintended collision 1
Entrapment of device or device component 1
Material erosion 1
Hole in material 1
Premature deployment 1
User used incorrect product for intended use 1
Material puncture 1
Sterility 1
Failure to osseointegrate 1
Dull 1
Device damaged prior to use 1
Defective component 1
Defective item 1
Device, removal of (non-implant) 1
Total Device Problems 3151

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 1 0 0 0 0 0 0 0
Class II 0 2 5 8 2 8 10 7 12 7
Class III 0 0 3 0 0 0 0 0 0 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 Apr-16-2012
11 Integra LifeSciences Corp. II Sep-16-2008
12 Integra LifeSciences Corporation II Jul-16-2013
13 Integra LifeSciences Corporation II Nov-02-2010
14 Medacta Usa II Nov-12-2014
15 OrthoPediatrics Corp II Nov-05-2012
16 Orthofix, Inc II Feb-28-2013
17 Orthofix, Inc II Nov-13-2009
18 Orthopediatrics Corp II May-12-2010
19 Pega Medical Inc. II Apr-29-2015
20 Pega Medical Inc. II Apr-02-2015
21 Pega Medical Inc. II Apr-18-2014
22 Pega Medical Inc. II Apr-10-2014
23 Pega Medical Inc. II Mar-02-2011
24 Smith & Nephew Inc II Apr-17-2013
25 Smith & Nephew Inc II Sep-16-2008
26 Stryker Howmedica Osteonics Corp. II Sep-13-2016
27 Stryker Howmedica Osteonics Corp. II Feb-25-2016
28 Stryker Howmedica Osteonics Corp. II Oct-14-2014
29 Stryker Howmedica Osteonics Corp. II Jan-28-2014
30 Stryker Howmedica Osteonics Corp. II Jul-31-2013
31 Stryker Howmedica Osteonics Corp. II Jul-16-2012
32 Stryker Howmedica Osteonics Corp. II Nov-09-2010
33 Stryker Howmedica Osteonics Corp. II Sep-02-2010
34 Stryker Howmedica Osteonics Corp. II Feb-24-2010
35 Stryker Howmedica Osteonics Corp. III Aug-18-2009
36 Stryker Spine II Nov-08-2011
37 Synthes (USA) Products LLC II Nov-19-2016
38 Synthes (USA) Products LLC II Dec-04-2015
39 Synthes (USA) Products LLC II Oct-15-2015
40 Synthes (USA) Products LLC II Jul-16-2015
41 Synthes USA (HQ), Inc. I Nov-09-2009
42 Synthes USA HQ, Inc. II Dec-10-2013
43 Synthes USA HQ, Inc. II Dec-05-2013
44 Synthes USA HQ, Inc. II Nov-25-2013
45 Synthes USA HQ, Inc. II Nov-20-2013
46 Synthes USA HQ, Inc. II Aug-26-2013
47 Synthes USA HQ, Inc. II Jul-23-2012
48 Synthes, Inc. II Jun-26-2015
49 Synthes, Inc. II May-12-2015
50 Synthes, Inc. II Mar-30-2015
51 Synthes, Inc. II Nov-14-2014
52 Tornier, Inc II Jul-29-2015
53 Vilex In Tennessee Inc II Jun-08-2015
54 Wright Medical Technology Inc II May-02-2012
55 Zimmer Gmbh II Oct-14-2015
56 Zimmer Inc. II Dec-28-2010
57 Zimmer Inc. II Nov-24-2009
58 Zimmer Inc. II Aug-04-2009
59 Zimmer Inc. II May-18-2009
60 Zimmer Manufacturing B.V. II May-16-2016
61 Zimmer Manufacturing B.V. II Mar-12-2016
62 Zimmer, Inc. II Jul-13-2015
63 Zimmer, Inc. II Feb-20-2014
64 Zimmer, Inc. II Dec-27-2013
65 Zimmer, Inc. II Nov-06-2012

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