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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device filler, bone void, calcium compound
Regulation Description Resorbable calcium salt bone void filler device.
Product CodeMQV
Regulation Number 888.3045
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASPINE USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BACTERIN INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
BIOCOMPOSITES LTD.
  SUBSTANTIALLY EQUIVALENT 9
BIOMET
  SUBSTANTIALLY EQUIVALENT 8
CENTERPULSE ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 3
CYTOPHIL INC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 5
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ETEX CORP.
  SUBSTANTIALLY EQUIVALENT 11
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
GLOBUS
  SUBSTANTIALLY EQUIVALENT 7
INION
  SUBSTANTIALLY EQUIVALENT 2
INTEGRA
  SUBSTANTIALLY EQUIVALENT 3
INTERPORE CROSS
  SUBSTANTIALLY EQUIVALENT 5
ISOTIS ORTHOBIOLOGICS, INC
  SUBSTANTIALLY EQUIVALENT 4
KENSEY NASH CORP.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 15
MUSCULOSKELETAL TRANSPLANT FOUNDATION
  SUBSTANTIALLY EQUIVALENT 9
NEXA ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
ORTHOVITA
  SUBSTANTIALLY EQUIVALENT 11
OSSACUR AG
  SUBSTANTIALLY EQUIVALENT 3
OSTEOBIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
OSTEOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 4
PENTAX
  SUBSTANTIALLY EQUIVALENT 1
PIONEER
  SUBSTANTIALLY EQUIVALENT 6
REGENERATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
SMITH & NEPHEW, INC.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 5
SYNTHES
  SUBSTANTIALLY EQUIVALENT 9
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 22

Device Problems
No Known Device Problem 84
Unknown (for use when the device problem is not known) 72
Not Applicable 17
No Information 13
Device operates differently than expected 12
Use of Device Issue 12
Break 12
Migration of device or device component 8
No code available 7
Shelf life exceeded 5
Device, or device fragments remain in patient 4
Failure to osseointegrate 4
Device Issue 4
Fracture 4
Device expiration issue 4
Material disintegration 3
Patient-device incompatibility 3
Incompatibility problem 3
Packaging issue 2
Positioning Issue 2
Metal shedding debris 2
Crack 2
Degraded 2
Difficult to insert 2
Leak 2
Product quality issue 2
Device remains implanted 1
Mislabeled 1
Delivered as unsterile product 1
Loose or intermittent connection 1
Method, improper/incorrect 1
Collapse 1
Contamination during use 1
Loss of or failure to bond 1
Filling problem 1
Size incorrect for patient 1
Incorrect or inadequate result 1
Material rigid or stiff 1
Material separation 1
Biocompatibility issue 1
Deployment issue 1
Device markings issue 1
Improper or incorrect procedure or method 1
Component missing 1
Implant, removal of 1
Unintended movement 1
Device packaging compromised 1
Device sensing issue 1
Difficult to open or close 1
Total Device Problems 310

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 1 2 0 3 3 2 2 2 2 1
Class III 1 4 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AlloSource, Inc. II May-06-2014
2 Apatech Limited II Jun-07-2016
3 Biostructures, LLC II Mar-16-2011
4 EBI, L.P. III Feb-14-2008
5 Globus Medical, Inc. II Oct-31-2013
6 Integra LifeSciences Corp II Feb-08-2012
7 Integra LifeSciences Corp II Mar-06-2009
8 Integra LifeSciences Corp. II Jun-12-2012
9 Interpore Cross International Inc III Feb-14-2008
10 LifeCell Corporation III Mar-26-2008
11 Michigan Orthopaedic Products, Inc. II Sep-17-2008
12 Musculoskeletal Transplant Foundation, Inc. II Apr-17-2015
13 Nanotherapeutics, Inc II Dec-02-2011
14 RTI Biologics, Inc. II Jun-23-2011
15 RTI Surgical, Inc. II Mar-10-2017
16 RTI Surgical, Inc. II Feb-07-2014
17 Skeletal Kinetics, Llc II Jul-24-2015
18 Surgical Tissue Network, Inc. II Jan-07-2013
19 Synthes (USA) Products LLC II Jun-09-2016
20 Synthes USA II Jan-11-2012
21 Teknimed SA III Feb-22-2007
22 Theken Spine LLC II Sep-03-2009
23 Theken Spine LLC III Sep-18-2008

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