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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device appliance, fixation, spinal intervertebral body
Regulation Description Spinal intervertebral body fixation orthosis.
Product CodeKWQ
Regulation Number 888.3060
Device Class 2


Premarket Reviews
ManufacturerDecision
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC HOLDINGS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AMENDIA, INC
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ATLAS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAPTIVA SPINE
  SUBSTANTIALLY EQUIVALENT 1
CHOICE SPINE, LP
  SUBSTANTIALLY EQUIVALENT 1
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
EISERTECH, LLC
  SUBSTANTIALLY EQUIVALENT 1
ELITE SURGICAL SUPPLIES (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 1
EVOLUTION SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 3
GLOBUS
  SUBSTANTIALLY EQUIVALENT 3
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 2
INTELLIGENT IMPLANT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
K2M
  SUBSTANTIALLY EQUIVALENT 3
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 3
KALITEC MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
L&K BIOMED CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DESIGNS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDITECH SPINE
  SUBSTANTIALLY EQUIVALENT 5
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
NEUROSTRUCTURES, INC
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 4
NVISION BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSSEUS FUSION SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI SANYOU MEDICAL CO, LTD
  SUBSTANTIALLY EQUIVALENT 1
SOLCO BIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPINEART
  SUBSTANTIALLY EQUIVALENT 2
SPINENET
  SUBSTANTIALLY EQUIVALENT 1
SPINEWAY
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL INSTRUMENT MANUFACTURERS, LLC
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES (USA) PRODUCTS LLC / MEDICAL DEVICE BUSINESS SERVICE
  SUBSTANTIALLY EQUIVALENT 1
TRANS1
  SUBSTANTIALLY EQUIVALENT 1
ULRICH MEDICAL USA
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
X-SPINE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
XTANT MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION, LLC
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 357
Adverse Event Without Identified Device or Use Problem 331
Migration or Expulsion of Device 200
Fracture 190
Migration 98
Mechanical Problem 84
Unintended Movement 64
Device Dislodged or Dislocated 60
Loose or Intermittent Connection 55
Device Operates Differently Than Expected 54
Material Deformation 54
Screw 52
Material Fragmentation 51
Material Integrity Problem 45
Detachment of Device or device Component 37
Insufficient Information 28
Material Separation 27
Device Slipped 26
Device-Device Incompatibility 26
Material Twisted / Bent 23
Bent 23
Mechanical Jam 20
Appropriate Term/Code Not Available 20
Dull, Blunt 17
Difficult to Remove 14
Malposition of device 14
Device Damaged by Another Device 14
Naturally Worn 14
No Apparent Adverse Event 12
Detachment Of Device Component 12
Sticking 11
Plate 10
Use of Device Problem 8
Fitting Problem 8
Biocompatibility 8
Device Operational Issue 8
Locking Mechanism 8
Loosening of Implant Not Related to Bone-Ingrowth 8
Positioning Problem 8
Torn Material 6
Failure to Osseointegrate 6
Improper or Incorrect Procedure or Method 5
Failure to Align 5
Ring 5
Misconnection 5
Material Distortion 5
Failure To Adhere Or Bond 4
Loss of Osseointegration 4
Device Issue 4
Deformation Due to Compressive Stress 4
Contamination / decontamination Problem 3
Metal Shedding Debris 3
Lock 3
Rod 3
Device Reprocessing Problem 3
Difficult To Position 3
Material Disintegration 3
Entrapment of Device 3
Difficult to Advance 3
Packaging Problem 3
Separation Problem 3
Patient Device Interaction Problem 2
Material Split, Cut or Torn 2
Device Contamination with Chemical or Other Material 2
Unintended Ejection 2
Difficult to Insert 2
Peeled / Delaminated 2
Disassembly 2
Material Discolored 2
Component Falling 2
Corroded 2
Crack 2
Unstable 2
Patient-Device Incompatibility 2
Device Markings / Labelling Problem 2
Expulsion 2
Extrusion 1
Fail-Safe Problem 1
Device Disinfection Or Sterilization Issue 1
Component or Accessory Incompatibility 1
Device Inoperable 1
Inadequacy of Device Shape and/or Size 1
Defective Device 1
Component Missing 1
Degraded 1
Spring 1
Off-Label Use 1
Product Quality Problem 1
Nonstandard device 1
Misassembled 1
Difficult to Interrogate 1
Material Erosion 1
Material Frayed 1
Manufacturing, Packaging or Shipping Problem 1
Material Protrusion / Extrusion 1
Handpiece 1
Ejection Problem 1
Screw Head 1
Device Difficult to Maintain 1
Unclear Information 1
Total Device Problems 2239

Recalls
Manufacturer Recall Class Date Posted
1 Alliance Partners LLC II Jul-07-2015
2 Alphatec Spine, Inc. II Apr-29-2015
3 Amendia, Inc II Dec-22-2016
4 Amendia, Inc dba Spinal Elements II Dec-13-2017
5 Biomet Spine, LLC II Nov-03-2015
6 Biomet Spine, LLC II Sep-09-2015
7 DePuy Spine, Inc. II Nov-19-2016
8 DePuy Spine, Inc. II Dec-21-2015
9 Exactech, Inc. II Jul-14-2015
10 Innovasis, Inc II May-20-2020
11 Innovasis, Inc II May-23-2017
12 Medtronic Sofamor Danek USA Inc II May-08-2018
13 SPINEART SA II Jan-13-2018
14 Synthes (USA) Products LLC II Apr-20-2016
15 Ulrich Medical USA Inc II Apr-26-2017
16 Zimmer Biomet Spine Inc. II Feb-22-2019

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