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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device fastener, fixation, nondegradable, soft tissue
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeMBI
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AMENDIA INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHOCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 13
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 9
BIOMET
  SUBSTANTIALLY EQUIVALENT 6
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 2
CAYENNE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
CONMED
  SUBSTANTIALLY EQUIVALENT 10
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 10
COUSIN BIOTECH S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
FIRST RAY LLC
  SUBSTANTIALLY EQUIVALENT 1
ICONN ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 4
KATOR LLC
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 4
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 6
MORTISE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
MTP SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 2
NCS LAB SRL
  SUBSTANTIALLY EQUIVALENT 1
OXFORD PERFORMANCE MATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PARCUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 6
PIVOT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PONTIS ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
PONTIS ORTHOPAEEICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
RIVERPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 11
STRYKER
  SUBSTANTIALLY EQUIVALENT 6
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 7
SUMMIT MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
THE ORTHOPEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 2
TORNIER INC.
  SUBSTANTIALLY EQUIVALENT 2
U & I CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 295
Fracture 213
Migration or Expulsion of Device 203
Adverse Event Without Identified Device or Use Problem 160
Insufficient Information 139
Positioning Failure 126
Material Separation 107
Activation, Positioning or Separation Problem 102
Material Split, Cut or Torn 50
Device-Device Incompatibility 49
Bent 45
Material Twisted / Bent 41
Material Fragmentation 35
Migration 32
Appropriate Term/Code Not Available 32
Material Frayed 31
Detachment Of Device Component 29
Mechanical Jam 29
Tip 26
Detachment of Device or device Component 23
Failure to Advance 23
Difficult to Insert 21
Device Operates Differently Than Expected 21
Positioning Problem 18
Expulsion 17
Wire 17
Crack 15
Device Dislodged or Dislocated 15
Loose or Intermittent Connection 14
Separation Failure 14
Premature Activation 14
Disassembly 13
Material Deformation 13
Difficult to Advance 12
Device Contamination with Chemical or Other Material 10
Loosening of Implant Not Related to Bone-Ingrowth 10
Suture 9
Device Markings / Labelling Problem 9
Unintended Movement 9
Mechanical Problem 9
Unsealed Device Packaging 8
Difficult To Position 8
Difficult to Remove 8
Component Missing 8
Device Damaged Prior to Use 7
Packaging Problem 7
Device Contaminated during manufacture or shipping 7
Device Packaging Compromised 6
Unknown (for use when the device problem is not known) 6
Misfire 6
Failure to Fire 6
Device Slipped 6
Delivered as Unsterile Product 6
Difficult or Delayed Positioning 6
Device Difficult to Setup or Prepare 5
Patient-Device Incompatibility 5
Deformation Due to Compressive Stress 5
Separation Problem 5
Component Misassembled 5
Failure to Eject 4
Activation Problem 4
Device Misassembled During Manufacturing / Shipping 4
Difficult or Delayed Activation 4
Use of Device Problem 4
Misassembled 4
Loss of or Failure to Bond 4
Screw 3
Failure to Discharge 3
Retraction Problem 3
Malposition of device 3
Improper or Incorrect Procedure or Method 3
Fitting Problem 3
Tear, Rip or Hole in Device Packaging 3
Device Operational Issue 3
Device Damaged by Another Device 3
Component or Accessory Incompatibility 3
Manufacturing, Packaging or Shipping Problem 3
Patient Device Interaction Problem 3
Device Handling Problem 2
Material Integrity Problem 2
Material Protrusion / Extrusion 2
Osseointegration Problem 2
Torn Material 2
Device Subassembly 2
Device Disinfection Or Sterilization Issue 2
Cut In Material 2
Device Or Device Fragments Location Unknown 2
Metal Shedding Debris 2
Sticking 2
Contamination During Use 2
Disconnection 2
Entrapment of Device 2
Deflation Problem 2
Guide 2
Pin 1
Shaft 1
Failure To Adhere Or Bond 1
Guidewire 1
Prong 1
Valve, PEEP (Positive End Expiratory Pressure) 1
Total Device Problems 2272

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Jan-11-2019
2 Biomet, Inc. II May-26-2016
3 ConMed Corporation II Dec-14-2017
4 EXP Pharmaceutical Services Corp II Jul-24-2015
5 OrthoPediatrics Corp II Aug-29-2014
6 Smith & Nephew, Inc. Endoscopy Division II Jul-14-2014
7 Stryker Corporation II May-10-2016
8 Synthes (USA) Products LLC II Jul-07-2016
9 The Anspach Effort, Inc. II Jun-25-2014
10 Valeris Medical, LLC II Oct-12-2018
11 Valeris Medical, LLC II Jul-13-2018
12 Zimmer Biomet, Inc. II Sep-26-2018
13 Zimmer Biomet, Inc. II May-23-2018
14 Zimmer Biomet, Inc. II Mar-15-2018
15 Zimmer Biomet, Inc. II Mar-14-2018
16 Zimmer Biomet, Inc. II Mar-01-2018

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