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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device plate, bone
Regulation Description Bone plate.
Product CodeJEY
Regulation Number 872.4760
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
AZARY TECHNOLOGIES LLC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 11
BIONX
  SUBSTANTIALLY EQUIVALENT 7
BIOPLATE, INC.
  SUBSTANTIALLY EQUIVALENT 16
CEREMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 3
IMPLANT INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 4
INION
  SUBSTANTIALLY EQUIVALENT 7
KARL LEIBINGER GMBH U. CO. KG
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 12
LINVATEC
  SUBSTANTIALLY EQUIVALENT 1
MACROPORE BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 3
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
MEDICON, E.G.
  SUBSTANTIALLY EQUIVALENT 7
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
MONDEAL MEDICAL SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1
OSTEOGENICS BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 7
POREX SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROSURG, INC.
  SUBSTANTIALLY EQUIVALENT 2
SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
STRAUMANN
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 14
SYNTHES
  SUBSTANTIALLY EQUIVALENT 42
TI-MESH, INC.
  SUBSTANTIALLY EQUIVALENT 2
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 15

Device Problems
Break 262
No Known Device Problem 123
Fracture 73
Unintended movement 49
No Information 39
Material fragmentation 37
Device operates differently than expected 32
Migration of device or device component 31
Loose or intermittent connection 18
Device inoperable 16
Difficult to insert 13
Device-device incompatibility 11
Detachment of device or device component 10
No code available 9
Failure to Adhere or Bond 8
Size incorrect for patient 8
Fitting problem 7
Difficult to position 7
Metal shedding debris 7
Malposition of device 6
Bent 5
Difficult to remove 4
Device expiration issue 4
Material deformation 4
Detachment of device component 4
Device or device fragments location unknown 3
Dull 3
Manufacturing or shipping issue associated with device 3
Dislodged or dislocated 3
Extrusion 3
Connection issue 2
Not Applicable 2
Patient-device incompatibility 2
Positioning Issue 2
Instruction for use issue 2
Biological environmental factor 2
Material Protrusion 2
Device Issue 2
Component or accessory incompatibility 2
Device or device component damaged by another device 1
Material separation 1
Sticking 1
Peeled 1
Implant, removal of 1
Component(s), broken 1
Slippage of device or device component 1
Packaging issue 1
Failure to align 1
Malfunction 1
Device, or device fragments remain in patient 1
Performance 1
Explanted 1
Use of Device Issue 1
Particulates 1
Difficult to deploy 1
Total Device Problems 836

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

Recalls
Manufacturer Recall Class Date Posted
1 Bioplate Inc II Nov-01-2011
2 Biomet Microfixation, Inc. II May-27-2011
3 Biomet Microfixation, Inc. II Oct-20-2010
4 Biomet Microfixation, Inc. III Jun-30-2010
5 Biomet Microfixation, Inc. III Mar-17-2010
6 Biomet Microfixation, Inc. II Nov-04-2008
7 Biomet Microfixation, Inc. II Sep-16-2008
8 Biomet Microfixation, LLC II Mar-23-2012
9 Stryker Craniomaxillofacial Division II Dec-16-2010
10 Stryker Leibinger USA II Dec-30-2008
11 Synthes (USA) Products LLC II Jun-07-2016
12 Synthes (USA) Products LLC II Jul-28-2015
13 Synthes USA (HQ), Inc. II Oct-26-2009
14 Synthes USA HQ, Inc. II Mar-12-2013
15 Walter Lorenz Surgical, Inc. II Jan-11-2012

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