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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device screw, fixation, bone
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeHWC
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
A.M. SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
AAP IMPLANTATE AG
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 9
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 3
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASCENT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIEDERMANN MEDTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 4
BIOMET INC
  SUBSTANTIALLY EQUIVALENT 2
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 1
CONMED
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 3
ENGINEERING CONSULTING SERVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXSOMED HOLDING COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
EXTREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
FEET FOR LIFE PODIATRY CENTER
  SUBSTANTIALLY EQUIVALENT 1
FIRST RAY LLC
  SUBSTANTIALLY EQUIVALENT 1
FLOWER ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FLOW-FX, LLC
  SUBSTANTIALLY EQUIVALENT 1
FOURNITURES HOSPITALIERES
  SUBSTANTIALLY EQUIVALENT 3
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 3
FUSION ORTHOPEDICS, LLC.
  SUBSTANTIALLY EQUIVALENT 5
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICONN ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 3
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
INFIX MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN GMBH and CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 4
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDSHAPE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
MEMPHIS ORTHOPAEDIC DESIGN, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERETE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 3
MX ORTHOPEDICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
NEOORTHO PRODUTOS ORTOPEDICOS S/A
  SUBSTANTIALLY EQUIVALENT 1
NEOSTEO
  SUBSTANTIALLY EQUIVALENT 3
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 3
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 5
NOVASTEP
  SUBSTANTIALLY EQUIVALENT 2
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
OVERMED SRL.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28
  SUBSTANTIALLY EQUIVALENT 2
PROVIDENCE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAFETYFIX MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIGN FRACTURE CARE INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMV SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 4
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 5
STRYKER TRAUMA AG
  SUBSTANTIALLY EQUIVALENT 1
STUCKENBROCK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SYNCHRO MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES USA PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
TORNIER
  SUBSTANTIALLY EQUIVALENT 1
TORNIER INC.
  SUBSTANTIALLY EQUIVALENT 1
TREACE MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
TYBER MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 5
TYBER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
VILEX IN TENNESSEE, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 10
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Adverse Event Without Identified Device or Use Problem 6077
Break 2793
Fracture 600
Migration 571
Insufficient Information 479
Migration or Expulsion of Device 385
Device-Device Incompatibility 382
Unintended Movement 379
No Apparent Adverse Event 321
Material Fragmentation 301
Material Twisted / Bent 211
Appropriate Term/Code Not Available 148
Material Separation 139
Device Operates Differently Than Expected 131
Loose or Intermittent Connection 125
Device Slipped 125
Loss of Osseointegration 124
Corroded 122
Device Dislodged or Dislocated 101
Screw 99
Material Deformation 88
Difficult to Remove 79
Failure to Align 68
Bent 64
Patient-Device Incompatibility 62
Fitting Problem 61
Manufacturing, Packaging or Shipping Problem 58
Detachment of Device or device Component 55
Patient Device Interaction Problem 53
Loosening of Implant Not Related to Bone-Ingrowth 53
Crack 51
Malposition of device 49
Mechanical Problem 48
Difficult to Insert 41
Use of Device Problem 38
Failure To Adhere Or Bond 37
Mechanical Jam 37
Failure to Advance 33
Difficult to Advance 32
Packaging Problem 32
Dull, Blunt 31
Osseointegration Problem 29
Component Missing 27
Material Frayed 26
Detachment Of Device Component 26
Positioning Problem 26
Entrapment of Device 25
Device Markings / Labelling Problem 24
Separation Failure 20
Positioning Failure 19
Material Discolored 19
Material Split, Cut or Torn 19
Naturally Worn 19
Noise, Audible 18
Material Erosion 18
Improper or Incorrect Procedure or Method 17
Component Incompatible 16
Metal Shedding Debris 16
Material Integrity Problem 15
Inadequacy of Device Shape and/or Size 14
Sticking 13
Loss of or Failure to Bond 13
Incomplete or Missing Packaging 13
Biocompatibility 13
Device Difficult to Maintain 12
Degraded 12
Activation, Positioning or Separation Problem 11
Peeled / Delaminated 11
Difficult To Position 10
Unstable 10
Flaked 9
Tip 9
Failure to Cut 9
Defective Device 8
Device Damaged by Another Device 8
Device Handling Problem 8
Unknown (for use when the device problem is not known) 7
Device Contamination with Chemical or Other Material 7
Plate 7
Device Packaging Compromised 6
Device Contaminated during manufacture or shipping 6
Delivered as Unsterile Product 6
Component or Accessory Incompatibility 6
Failure to Osseointegrate 6
Missing Value Reason 5
Unsealed Device Packaging 5
Device Inoperable 5
Screw Head 5
Device Damaged Prior to Use 5
Difficult or Delayed Positioning 5
Extrusion 5
Collapse 4
Material Distortion 4
Biofilm coating in Device 4
Device Operational Issue 4
Mechanics Altered 4
Retraction Problem 4
Disassembly 4
Device Expiration Issue 4
Tear, Rip or Hole in Device Packaging 4
Total Device Problems 15367

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Mar-17-2020
2 Biomet II Jun-09-2020
3 Biomet, Inc. II May-26-2016
4 Biomet, Inc. II Jul-01-2015
5 Cayenne Medical Inc. II Jul-10-2018
6 CrossRoads Extremity Systems, LLC II Oct-24-2019
7 DePuy Mitek, Inc., a Johnson & Johnson Co. II Jun-20-2017
8 Flower Orthopedics Corporation II Mar-24-2015
9 In2Bones, SAS II Dec-09-2015
10 In2Bones, SAS II Mar-25-2015
11 In2bones USA, LLC II Aug-21-2018
12 Integra LifeSciences Corp. II Aug-19-2016
13 Integra Limited II Apr-05-2019
14 MicroAire Surgical Instruments, LLC II Jul-27-2016
15 MicroPort Orthopedics Inc. II Oct-11-2018
16 Nextremity Solutions II Feb-24-2020
17 Nextremity Solutions II Jan-03-2020
18 ORTHO SOLUTIONS, LTD. II Mar-09-2018
19 Ortho Solutions Inc II Sep-16-2016
20 Ortho Solutions Inc II Oct-06-2015
21 OrthoPediatrics Corp II Sep-19-2016
22 PROVIDENCE MEDICAL TECHNOLOGIES II Jun-25-2020
23 Pega Medical Inc. II Nov-20-2015
24 Pega Medical Inc. II Jun-26-2015
25 Smith & Nephew, Inc. II Mar-20-2018
26 Smith & Nephew, Inc. II Apr-18-2017
27 Stryker Corporation II Mar-02-2018
28 Stryker Howmedica Osteonics Corp. II Apr-18-2016
29 Synthes (USA) Products LLC II Oct-24-2018
30 Synthes (USA) Products LLC II Jul-11-2016
31 Synthes (USA) Products LLC II Apr-27-2016
32 Synthes (USA) Products LLC II Nov-20-2015
33 Synthes (USA) Products LLC II Sep-18-2015
34 Synthes, Inc. II Jun-15-2015
35 Trilliant Surgical Ltd. II Jan-06-2017
36 Trilliant Surgical Ltd. II Nov-17-2016
37 Trilliant Surgical Ltd. II Aug-26-2015
38 Trilliant Surgical Ltd. II Aug-19-2015
39 Trilliant Surgical, LLC II Mar-30-2020
40 Wright Medical Technology, Inc. II Nov-25-2019
41 Wright Medical Technology, Inc. II May-18-2015
42 Zimmer Biomet, Inc. II Nov-07-2019
43 Zimmer Biomet, Inc. II May-09-2019
44 Zimmer Biomet, Inc. II Sep-14-2018
45 Zimmer Biomet, Inc. II May-08-2018
46 Zimmer Biomet, Inc. II Mar-15-2018
47 Zimmer Biomet, Inc. II Feb-16-2017
48 Zimmer Biomet, Inc. II Jan-13-2016
49 Zimmer Manufacturing B.V. II May-16-2016
50 Zimmer Manufacturing B.V. II Mar-12-2016

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