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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
Screw 7
Material Deformation 7
Material Fragmentation 6
Spacer 5
Use of Device Problem 5
Loose or Intermittent Connection 4
Device Markings / Labelling Problem 3
Device-Device Incompatibility 3
Patient Device Interaction Problem 3
Inadequacy of Device Shape and/or Size 3
Fitting Problem 2
Detachment Of Device Component 2
Crack 2
Positioning Problem 2
Disassembly 2
Material Integrity Problem 2
Plate 2
Unsealed Device Packaging 1
Difficult To Position 1
Connecting Rod 1
Component Missing 1
Improper or Incorrect Procedure or Method 1
Device Difficult to Setup or Prepare 1
Device Operational Issue 1
Naturally Worn 1
Off-Label Use 1
Disconnection 1
Unstable 1
Structural Problem 1
No Device Output 1
Difficult to Insert 1
Patient-Device Incompatibility 1
Computer Software Problem 1
Inflation Problem 1
Peeled / Delaminated 1
Split 1
Material Twisted / Bent 1
Insufficient Information 1
Torn Material 1
Device Expiration Issue 1
Device Or Device Fragments Location Unknown 1
Fluid Leak 1
Packaging Problem 1
Material Separation 1
Loss of or Failure to Bond 1
Mechanical Jam 1
Defective Device 1
Device Damaged by Another Device 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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