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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 467
No Known Device Problem 428
Fracture 207
Implant, removal of 197
Migration of device or device component 141
Device operates differently than expected 118
Fitting problem 80
No Information 76
Failure to align 68
Displacement 63
Component(s), broken 60
Unintended movement 45
No code available 43
Mechanical jam 38
Device remains implanted 36
Unknown (for use when the device problem is not known) 35
Difficult to insert 33
Device handling issue 32
Device packaging compromised 29
Other (for use when an appropriate device code cannot be identified) 28
Sticking 24
Nonstandard device or device component 23
Difficult to remove 22
Bent 19
Malfunction 14
Malposition of device 14
Detachment of device component 13
Size incorrect for patient 11
Material fragmentation 10
Explanted 10
Material deformation 10
Device markings issue 10
Loose or intermittent connection 9
Failure to Adhere or Bond 9
Loss of or failure to bond 8
Dislodged 8
Improper or incorrect procedure or method 8
Use of Device Issue 7
Material integrity issue 7
Detachment of device or device component 6
Noise, Audible 6
Disengaged 6
Corrosion 5
Delivered as unsterile product 5
Mechanical issue 5
Failure to advance 5
Tear, rip or hole in device packaging 5
Positioning Issue 5
Implant breakage or physical damage 4
Foreign material present in device 4
Incompatibility problem 4
Metal shedding debris 4
Difficult to position 4
Loose 4
Crack 4
Failure to deploy 3
Disassembly 3
Collapse 3
Foreign material 3
Unstable 3
Difficult to advance 3
Dislodged or dislocated 3
Mechanics altered 3
Material Protrusion 2
Deployment issue 2
Device-device incompatibility 2
Tip breakage 2
Device inoperable 2
Unsealed device packaging 2
Device, or device fragments remain in patient 2
Slippage of device or device component 2
Shelf life exceeded 2
Component missing 2
Device Issue 2
Failure to disconnect 2
Failure to separate 2
Device expiration issue 2
Material discolored 2
Component incompatible 2
Entrapment of device or device component 1
Material erosion 1
Component falling 1
Device Cleaning Issue 1
Hole in material 1
Premature deployment 1
User used incorrect product for intended use 1
Material puncture 1
Unintended collision 1
Defective item 1
Device, removal of (non-implant) 1
Dent in material 1
Implant Mobility NOS (Not otherwise specified) 1
Device damaged prior to use 1
Defective component 1
Cut in material 1
Sterility 1
Failure to osseointegrate 1
Device or device component damaged by another device 1
Patient-device incompatibility 1
Material Distortion 1
Total Device Problems 2613

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 5
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 Feb-25-2016
27 Stryker Howmedica Osteonics Corp. II Oct-14-2014
28 Stryker Howmedica Osteonics Corp. II Jan-28-2014
29 Stryker Howmedica Osteonics Corp. II Jul-31-2013
30 Stryker Howmedica Osteonics Corp. II Jul-16-2012
31 Stryker Howmedica Osteonics Corp. II Nov-09-2010
32 Stryker Howmedica Osteonics Corp. II Sep-02-2010
33 Stryker Howmedica Osteonics Corp. II Feb-24-2010
34 Stryker Howmedica Osteonics Corp. III Aug-18-2009
35 Stryker Spine II Nov-08-2011
36 Synthes (USA) Products LLC II Dec-04-2015
37 Synthes (USA) Products LLC II Oct-15-2015
38 Synthes (USA) Products LLC II Jul-16-2015
39 Synthes USA (HQ), Inc. I Nov-09-2009
40 Synthes USA HQ, Inc. II Dec-10-2013
41 Synthes USA HQ, Inc. II Dec-05-2013
42 Synthes USA HQ, Inc. II Nov-25-2013
43 Synthes USA HQ, Inc. II Nov-20-2013
44 Synthes USA HQ, Inc. II Aug-26-2013
45 Synthes USA HQ, Inc. II Jul-23-2012
46 Synthes, Inc. II Jun-26-2015
47 Synthes, Inc. II May-12-2015
48 Synthes, Inc. II Mar-30-2015
49 Synthes, Inc. II Nov-14-2014
50 Tornier, Inc II Jul-29-2015
51 Vilex In Tennessee Inc II Jun-08-2015
52 Wright Medical Technology Inc II May-02-2012
53 Zimmer Gmbh II Oct-14-2015
54 Zimmer Inc. II Dec-28-2010
55 Zimmer Inc. II Nov-24-2009
56 Zimmer Inc. II Aug-04-2009
57 Zimmer Inc. II May-18-2009
58 Zimmer Manufacturing B.V. II May-16-2016
59 Zimmer Manufacturing B.V. II Mar-12-2016
60 Zimmer, Inc. II Jul-13-2015
61 Zimmer, Inc. II Feb-20-2014
62 Zimmer, Inc. II Dec-27-2013
63 Zimmer, Inc. II Nov-06-2012

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