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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 7
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 422
No Known Device Problem 357
Implant, removal of 197
Fracture 196
Migration of device or device component 122
Device operates differently than expected 104
No Information 73
Fitting problem 69
Displacement 63
Failure to align 62
Component(s), broken 60
No code available 43
Unintended movement 37
Device remains implanted 36
Unknown (for use when the device problem is not known) 35
Difficult to insert 32
Mechanical jam 30
Device packaging compromised 28
Other (for use when an appropriate device code cannot be identified) 28
Sticking 24
Nonstandard device or device component 23
Difficult to remove 20
Bent 18
Malfunction 14
Malposition of device 14
Detachment of device component 12
Device handling issue 12
Size incorrect for patient 11
Explanted 10
Loose or intermittent connection 9
Dislodged 8
Material deformation 8
Material fragmentation 8
Loss of or failure to bond 8
Failure to Adhere or Bond 8
Improper or incorrect procedure or method 8
Material integrity issue 7
Use of Device Issue 7
Device markings issue 7
Disengaged 6
Mechanical issue 5
Detachment of device or device component 5
Noise, Audible 5
Tear, rip or hole in device packaging 5
Failure to advance 5
Corrosion 5
Incompatibility problem 4
Implant breakage or physical damage 4
Difficult to position 4
Positioning Issue 4
Loose 4
Foreign material present in device 4
Failure to deploy 3
Mechanics altered 3
Difficult to advance 3
Crack 3
Collapse 3
Foreign material 3
Unstable 3
Metal shedding debris 3
Disassembly 3
Dislodged or dislocated 3
Component missing 2
Tip breakage 2
Device inoperable 2
Device, or device fragments remain in patient 2
Device expiration issue 2
Shelf life exceeded 2
Slippage of device or device component 2
Failure to disconnect 2
Material Protrusion 2
Component incompatible 2
Device Issue 2
Failure to separate 2
Device-device incompatibility 2
Unintended collision 1
Dent in material 1
Device, removal of (non-implant) 1
Device or device component damaged by another device 1
Hole in material 1
Unsealed device packaging 1
User used incorrect product for intended use 1
Misassembled by Users 1
Component falling 1
Entrapment of device or device component 1
Material erosion 1
Device damaged prior to use 1
Material Distortion 1
Premature deployment 1
Packaging issue 1
Defective item 1
Cut in material 1
Patient-device incompatibility 1
Device Cleaning Issue 1
Sterility 1
Failure to osseointegrate 1
Implant Mobility NOS (Not otherwise specified) 1
Material discolored 1
Defective component 1
Deployment issue 1
Total Device Problems 2371

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

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