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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device spinal vertebral body replacement device
Regulation Description Spinal intervertebral body fixation orthosis.
Product CodeMQP
Regulation Number 888.3060
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP IMPLANT SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 2
AMENDIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE/MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHOICE SPINE
  SUBSTANTIALLY EQUIVALENT 2
DEPUY SYNTHES SPINE
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS
  SUBSTANTIALLY EQUIVALENT 3
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 1
K2M
  SUBSTANTIALLY EQUIVALENT 2
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 1
LDR SPINE USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 4
OXFORD PERFORMANCE MATERIALS
  SUBSTANTIALLY EQUIVALENT 1
SIGNUS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ULRICH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
ULRICH MEDICAL USA
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 219
Break 88
Migration or Expulsion of Device 74
Migration 36
No Apparent Adverse Event 29
Unintended Movement 25
Fracture 23
Device Dislodged or Dislocated 20
Device Operates Differently Than Expected 19
Appropriate Term/Code Not Available 17
Detachment of Device or device Component 15
Mechanical Problem 13
Device Slipped 10
Collapse 9
Malposition of device 8
Material Deformation 7
Screw 7
Material Fragmentation 6
Spacer 5
Use of Device Problem 5
Loose or Intermittent Connection 4
Inadequacy of Device Shape and/or Size 3
Device Markings / Labelling Problem 3
Patient Device Interaction Problem 3
Device-Device Incompatibility 3
Positioning Problem 2
Fitting Problem 2
Material Integrity Problem 2
Plate 2
Detachment Of Device Component 2
Crack 2
Disassembly 2
Disconnection 1
Device Expiration Issue 1
Fluid Leak 1
Inflation Problem 1
Difficult to Insert 1
Computer Software Problem 1
Loss of or Failure to Bond 1
Connecting Rod 1
Improper or Incorrect Procedure or Method 1
Unstable 1
No Device Output 1
Unsealed Device Packaging 1
Peeled / Delaminated 1
Difficult To Position 1
Device Difficult to Setup or Prepare 1
Off-Label Use 1
Material Separation 1
Material Twisted / Bent 1
Mechanical Jam 1
Naturally Worn 1
Device Operational Issue 1
Device Damaged by Another Device 1
Packaging Problem 1
Component Missing 1
Structural Problem 1
Split 1
Defective Device 1
Device Or Device Fragments Location Unknown 1
Patient-Device Incompatibility 1
Torn Material 1
Insufficient Information 1
Total Device Problems 696

Recalls
Manufacturer Recall Class Date Posted
1 Atlas Spine, Inc. II May-06-2016
2 Eden Spine Europe SA II May-12-2017
3 Synthes USA (HQ), Inc. II Jun-26-2015
4 Synthes, Inc. II Jun-02-2014

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