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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 and 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 17
SYNTHES
  SUBSTANTIALLY EQUIVALENT 42
TI-MESH, INC.
  SUBSTANTIALLY EQUIVALENT 2
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 15

Device Problems
Break 346
No Known Device Problem 206
Fracture 151
No Information 58
Unintended movement 51
Material fragmentation 51
Migration of device or device component 44
Device inoperable 44
Material deformation 40
Device operates differently than expected 39
Size incorrect for patient 18
Loose or intermittent connection 18
Difficult to insert 15
Material Protrusion 13
No code available 12
Failure to Adhere or Bond 12
Fitting problem 11
Device-device incompatibility 11
Detachment of device or device component 10
Malposition of device 9
Difficult to position 9
Dull 7
Bent 7
Metal shedding debris 7
Patient-device incompatibility 6
Dislodged or dislocated 6
Noise, Audible 5
Difficult to remove 5
Detachment of device component 4
Device expiration issue 4
Sticking 3
Extrusion 3
Manufacturing or shipping issue associated with device 3
Failure to advance 3
Device or device fragments location unknown 3
Device Issue 2
Biological environmental factor 2
Component or accessory incompatibility 2
Connection issue 2
Device or device component damaged by another device 2
Not Applicable 2
Osseointegration issue 2
Slippage of device or device component 2
Material separation 2
Malfunction 2
Instruction for use issue 2
Peeled 2
Performance 1
Particulates 1
Explanted 1
Difficult to deploy 1
Material discolored 1
Component(s), broken 1
Structural problem 1
Failure to align 1
Implant, removal of 1
Use of Device Issue 1
Product quality issue 1
Device, or device fragments remain in patient 1
Packaging issue 1
Positioning Issue 1
Material Distortion 1
Device markings issue 1
Total Device Problems 1274

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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