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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 4
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 10
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 77
Unknown (for use when the device problem is not known) 72
Not Applicable 15
Break 12
No Information 11
Use of Device Issue 9
Device operates differently than expected 8
Migration of device or device component 7
No code available 7
Device, or device fragments remain in patient 4
Fracture 4
Device Issue 4
Failure to osseointegrate 4
Shelf life exceeded 3
Patient-device incompatibility 3
Material disintegration 3
Incompatibility problem 3
Device expiration issue 2
Product quality issue 2
Crack 2
Degraded 2
Packaging issue 2
Positioning Issue 2
Metal shedding debris 2
Size incorrect for patient 1
Improper or incorrect procedure or method 1
Component missing 1
Implant, removal of 1
Device packaging compromised 1
Biocompatibility issue 1
Deployment issue 1
Device markings issue 1
Collapse 1
Contamination during use 1
Difficult to insert 1
Leak 1
Method, improper/incorrect 1
Device remains implanted 1
Incorrect or inadequate result 1
Material rigid or stiff 1
Filling problem 1
Mislabeled 1
Delivered as unsterile product 1
Device handling issue 1
Total Device Problems 280

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 2 0 3 3 2 2 2 2
Class III 1 4 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 Feb-07-2014
16 Skeletal Kinetics, Llc II Jul-24-2015
17 Surgical Tissue Network, Inc. II Jan-07-2013
18 Synthes (USA) Products LLC II Jun-09-2016
19 Synthes USA II Jan-11-2012
20 Teknimed SA III Feb-22-2007
21 Theken Spine LLC II Sep-03-2009
22 Theken Spine LLC III Sep-18-2008

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