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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device rod, fixation, intramedullary and accessories
Regulation Description Intramedullary fixation rod.
Product CodeHSB
Regulation Number 888.3020
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 3
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH 200, LLC
  SUBSTANTIALLY EQUIVALENT 1
CITIEFFE S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
DOUBLE MEDICAL TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
ELLIPSE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
FOURNITURES HOSPITALIERES
  SUBSTANTIALLY EQUIVALENT 2
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTRAFUSE LLC
  SUBSTANTIALLY EQUIVALENT 2
MEDSHAPE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
MERETE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 3
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC DESIGNS NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
PEGA MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
RENOVO LIFE LLC
  SUBSTANTIALLY EQUIVALENT 1
SIGN FRACTURE CARE INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
SONOMA ORTHOPEDIC PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 4
SYNTEC SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
SYNTHES (USA) PRODUCTS LLC / MEDICAL DEVICE BUSINESS SERVICE
  SUBSTANTIALLY EQUIVALENT 2
THE ORTHOPEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
TRUEMED GROUP LLC
  SUBSTANTIALLY EQUIVALENT 1
WITTENSTEIN INTENS GMBH
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Adverse Event Without Identified Device or Use Problem 2251
Break 1813
Device-Device Incompatibility 644
Fracture 478
Migration 361
Migration or Expulsion of Device 339
Device Operates Differently Than Expected 300
Packaging Problem 266
Device Contaminated during manufacture or shipping 260
Failure to Align 235
Unintended Movement 199
Delivered as Unsterile Product 198
Insufficient Information 172
Fitting Problem 132
Mechanical Jam 129
Appropriate Term/Code Not Available 89
Device Handling Problem 62
Mechanical Problem 60
Difficult to Insert 58
Material Twisted / Bent 57
Difficult to Remove 55
Material Discolored 55
Device Packaging Compromised 52
No Apparent Adverse Event 45
Use of Device Problem 44
Material Deformation 43
Screw 36
Material Fragmentation 36
Defective Device 32
Sticking 31
Unsealed Device Packaging 31
Malposition of device 29
Bent 29
Failure To Adhere Or Bond 28
Difficult to Advance 25
Detachment of Device or device Component 25
Contamination / decontamination Problem 24
Nonstandard device 23
Tear, Rip or Hole in Device Packaging 21
Inadequacy of Device Shape and/or Size 20
Failure to Advance 20
Connection Problem 19
Improper or Incorrect Procedure or Method 18
Crack 18
Disassembly 15
Difficult To Position 15
Entrapment of Device 15
Device Markings / Labelling Problem 14
Positioning Problem 14
Component Missing 13
Device Difficult to Maintain 13
Device Dislodged or Dislocated 12
Material Integrity Problem 12
Device Contamination with Chemical or Other Material 11
Loss of Osseointegration 11
Activation Failure Including Expansion Failures 11
Loose or Intermittent Connection 11
Defective Component 11
Out-Of-Box Failure 10
Inflation Problem 10
Tip 9
Device Damaged by Another Device 9
Incomplete or Missing Packaging 9
Device Slipped 8
Corroded 8
Positioning Failure 8
Noise, Audible 7
Off-Label Use 7
Unstable 7
Device Damaged Prior to Use 7
Difficult or Delayed Positioning 7
Detachment Of Device Component 7
Patient Device Interaction Problem 7
Failure to Osseointegrate 6
Material Separation 6
Physical Resistance / Sticking 6
Device Operational Issue 6
Separation Failure 6
Patient-Device Incompatibility 5
Loss of or Failure to Bond 5
Failure to Disconnect 5
Misassembled 5
Compatibility Problem 5
Loosening of Implant Not Related to Bone-Ingrowth 5
Device Disinfection Or Sterilization Issue 4
Device Expiration Issue 4
Misassembly by Users 4
Manufacturing, Packaging or Shipping Problem 4
Naturally Worn 4
Difficult or Delayed Separation 4
Activation, Positioning or Separation Problem 4
Mechanics Altered 3
Device Difficult to Setup or Prepare 3
Material Distortion 3
Thread 3
Separation Problem 3
Rod 3
Collapse 3
Torn Material 3
Dull, Blunt 3
Total Device Problems 9275

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-26-2016
2 CarboFix Orthopedics, Ltd. II Jun-14-2016
3 Integra LifeSciences Corp. II Mar-23-2017
4 Ortho Solutions Inc II Jul-28-2017
5 OrthoPediatrics Corp II Oct-25-2019
6 OrthoPediatrics Corp II Oct-13-2019
7 OrthoPediatrics Corp III Dec-22-2016
8 Pega Medical Inc. II Aug-14-2019
9 Pega Medical Inc. II Apr-29-2015
10 Pega Medical Inc. II Apr-02-2015
11 Stryker GmbH II Aug-22-2018
12 Stryker GmbH II Jul-10-2018
13 Stryker Howmedica Osteonics Corp. II Sep-13-2016
14 Stryker Howmedica Osteonics Corp. II Feb-25-2016
15 Synthes (USA) Products LLC II Feb-13-2018
16 Synthes (USA) Products LLC II Nov-19-2016
17 Synthes (USA) Products LLC II Dec-04-2015
18 Synthes (USA) Products LLC II Oct-15-2015
19 Synthes (USA) Products LLC II Jul-16-2015
20 Synthes, Inc. II Jun-26-2015
21 Synthes, Inc. II May-12-2015
22 Synthes, Inc. II Mar-30-2015
23 Tornier, Inc II Jul-29-2015
24 Vilex In Tennessee Inc II Jun-08-2015
25 Wright Medical Technology, Inc. II Nov-25-2019
26 Wright Medical Technology, Inc. II Apr-13-2018
27 Zimmer Biomet, Inc. II Nov-07-2019
28 Zimmer Biomet, Inc. II Nov-14-2018
29 Zimmer Biomet, Inc. II Oct-18-2018
30 Zimmer Biomet, Inc. II Sep-25-2018
31 Zimmer Biomet, Inc. II Sep-13-2018
32 Zimmer Biomet, Inc. II Apr-25-2018
33 Zimmer Biomet, Inc. II Apr-20-2018
34 Zimmer Biomet, Inc. II Mar-27-2018
35 Zimmer Biomet, Inc. II Mar-14-2018
36 Zimmer Biomet, Inc. II Mar-14-2018
37 Zimmer Biomet, Inc. II Jan-29-2018
38 Zimmer Biomet, Inc. II Jun-15-2017
39 Zimmer Biomet, Inc. II Jun-01-2017
40 Zimmer Biomet, Inc. II Mar-20-2017
41 Zimmer Gmbh II Oct-14-2015
42 Zimmer Manufacturing B.V. II May-16-2016
43 Zimmer Manufacturing B.V. II Mar-12-2016
44 Zimmer, Inc. II Jul-13-2015

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