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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 278
No Known Device Problem 129
Fracture 82
Unintended movement 49
Material fragmentation 40
No Information 39
Device operates differently than expected 33
Migration of device or device component 32
Device inoperable 21
Loose or intermittent connection 18
Difficult to insert 15
Device-device incompatibility 11
Detachment of device or device component 10
No code available 10
Size incorrect for patient 9
Failure to Adhere or Bond 8
Difficult to position 7
Metal shedding debris 7
Fitting problem 7
Malposition of device 6
Patient-device incompatibility 5
Material deformation 5
Bent 5
Detachment of device component 4
Device expiration issue 4
Difficult to remove 4
Sticking 3
Dull 3
Dislodged or dislocated 3
Extrusion 3
Manufacturing or shipping issue associated with device 3
Device or device fragments location unknown 3
Device Issue 2
Biological environmental factor 2
Component or accessory incompatibility 2
Connection issue 2
Material Protrusion 2
Not Applicable 2
Slippage of device or device component 2
Instruction for use issue 2
Particulates 1
Peeled 1
Performance 1
Explanted 1
Difficult to deploy 1
Material discolored 1
Component(s), broken 1
Material separation 1
Device, or device fragments remain in patient 1
Malfunction 1
Failure to align 1
Failure to advance 1
Implant, removal of 1
Use of Device Issue 1
Packaging issue 1
Positioning Issue 1
Material Distortion 1
Device or device component damaged by another device 1
Total Device Problems 890

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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