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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cerclage, fixation
Regulation Description Bone fixation cerclage.
Product CodeJDQ
Regulation Number 888.3010
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
DSM BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FRONTIER MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 3
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN GMBH and CO. KG
  SUBSTANTIALLY EQUIVALENT 1
PIONEER
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
RTI SURGICAL, INC. (DBA RTI BIOLOGICS, INC.)
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Adverse Event Without Identified Device or Use Problem 157
Device Operates Differently Than Expected 149
Break 134
Mechanical Problem 45
Insufficient Information 44
Fracture 33
Unintended Movement 15
Component Missing 13
Failure To Adhere Or Bond 12
Mechanical Jam 11
Device-Device Incompatibility 9
No Apparent Adverse Event 8
Bent 8
Sticking 7
Loose or Intermittent Connection 6
Material Deformation 6
Material Integrity Problem 5
Device Dislodged or Dislocated 5
Device Operational Issue 4
Device Difficult to Maintain 4
Device Handling Problem 4
Material Frayed 4
Device Issue 4
Device Slipped 4
Dull, Blunt 4
Migration or Expulsion of Device 4
Material Fragmentation 3
Corroded 3
Inadequacy of Device Shape and/or Size 3
Appropriate Term/Code Not Available 3
Device Packaging Compromised 2
Difficult to Open or Close 2
Incorrect Device Or Component Shipped 2
Difficult to Insert 2
Detachment of Device or device Component 2
Cable 2
Plate 2
Crack 1
Degraded 1
Disassembly 1
Material Disintegration 1
Detachment Of Device Component 1
Contamination During Use 1
Delivered as Unsterile Product 1
Difficult To Position 1
Device Difficult to Setup or Prepare 1
Off-Label Use 1
Material Separation 1
Tear, Rip or Hole in Device Packaging 1
Loss of Osseointegration 1
Failure to Cut 1
Defective Device 1
Activation, Positioning or Separation Problem 1
Unraveled Material 1
Use of Device Problem 1
Improper or Incorrect Procedure or Method 1
Fitting Problem 1
Microbial Contamination of Device 1
Manufacturing, Packaging or Shipping Problem 1
Device Contamination with Chemical or Other Material 1
Packaging Problem 1
Positioning Problem 1
Material Distortion 1
Migration 1
Total Device Problems 752

Recalls
Manufacturer Recall Class Date Posted
1 EXP Pharmaceutical Services Corp II Jul-24-2015
2 PIONEER SURGICAL TECHNOLOGY, INC. II Jul-17-2014
3 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Jul-09-2015
4 Synthes (USA) Products LLC II Nov-14-2015
5 Synthes (USA) Products LLC II Aug-27-2015

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