• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
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
RTI SURGICAL, INC. (DBA RTI BIOLOGICS, INC.)
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 180
Adverse Event Without Identified Device or Use Problem 176
Device Operates Differently Than Expected 148
Mechanical Problem 77
Insufficient Information 51
Fracture 39
Unintended Movement 15
Component Missing 13
Device-Device Incompatibility 12
Failure To Adhere Or Bond 12
Mechanical Jam 11
No Apparent Adverse Event 11
Migration or Expulsion of Device 9
Bent 7
Sticking 7
Device Difficult to Maintain 7
Loose or Intermittent Connection 6
Device Slipped 6
Material Frayed 6
Material Deformation 6
Device Dislodged or Dislocated 5
Device Handling Problem 5
Device Issue 4
Material Integrity Problem 4
Dull, Blunt 4
Material Fragmentation 4
Corroded 4
Device Operational Issue 4
Appropriate Term/Code Not Available 4
Inadequacy of Device Shape and/or Size 3
Use of Device Problem 2
Device Packaging Compromised 2
Difficult to Open or Close 2
Incorrect Device Or Component Shipped 2
Plate 2
Cable, Electrical 2
Device Difficult to Setup or Prepare 2
Difficult to Insert 2
Detachment of Device or Device Component 2
Manufacturing, Packaging or Shipping Problem 1
Off-Label Use 1
Contamination 1
Degraded 1
Improper or Incorrect Procedure or Method 1
Connection Problem 1
Activation, Positioning or SeparationProblem 1
Material Split, Cut or Torn 1
Material Distortion 1
Disassembly 1
Material Disintegration 1
Unraveled Material 1
Packaging Problem 1
Loss of Osseointegration 1
Failure to Cut 1
Defective Device 1
Fitting Problem 1
Microbial Contamination of Device 1
Tear, Rip or Hole in Device Packaging 1
Loss of or Failure to Bond 1
Detachment Of Device Component 1
Crack 1
Material Separation 1
Delivered as Unsterile Product 1
Device Contamination with Chemical or Other Material 1
Positioning Problem 1
Total Device Problems 884

Recalls
Manufacturer Recall Class Date Posted
1 Alto Development Corp II Oct-30-2019
2 EXP Pharmaceutical Services Corp II Jul-24-2015
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

-
-