• 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 plate, bone
Regulation Description Bone plate.
Product CodeJEY
Regulation Number 872.4760
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 2
FLEXTRONICS INTERNATIONAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 4
KLS MARTIN GMBH and CO. KG
  SUBSTANTIALLY EQUIVALENT 4
MATRIX SURGICAL HOLDINGS, LLC/MATRIX SURGICAL USA
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED L.P.
  SUBSTANTIALLY EQUIVALENT 1
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER
  SUBSTANTIALLY EQUIVALENT 8
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 8
SURGIDENT
  SUBSTANTIALLY EQUIVALENT 1
VISIONARE LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 689
Break 646
Fracture 253
Insufficient Information 117
Unintended Movement 70
Migration or Expulsion of Device 70
Material Fragmentation 66
Device-Device Incompatibility 64
Material Deformation 62
Device Slipped 49
Device Operates Differently Than Expected 43
Difficult to Insert 41
No Apparent Adverse Event 37
Inadequacy of Device Shape and/or Size 32
Device Inoperable 23
Patient-Device Incompatibility 20
Device Dislodged or Dislocated 19
Malposition of device 18
Loose or Intermittent Connection 18
Screw 17
Material Twisted / Bent 15
Device Appears to Trigger Rejection 15
Fitting Problem 12
Dull, Blunt 12
Failure To Adhere Or Bond 12
Material Protrusion / Extrusion 12
Appropriate Term/Code Not Available 12
Detachment of Device or device Component 12
Osseointegration Problem 12
Migration 11
Patient Device Interaction Problem 10
Loosening of Implant Not Related to Bone-Ingrowth 10
Difficult To Position 9
Manufacturing, Packaging or Shipping Problem 9
Device Markings / Labelling Problem 9
Difficult to Advance 8
Bent 7
Failure to Advance 7
Metal Shedding Debris 7
Noise, Audible 7
Biocompatibility 6
Plate 6
Defective Device 6
Use of Device Problem 6
Material Integrity Problem 5
Detachment Of Device Component 5
Difficult to Remove 5
Naturally Worn 5
Loss of Osseointegration 4
Device Expiration Issue 4
Expulsion 4
Device Or Device Fragments Location Unknown 3
Device Issue 3
Premature Separation 3
Extrusion 3
Device Contamination with Body Fluid 3
Improper or Incorrect Procedure or Method 2
Biofilm coating in Device 2
Device Operational Issue 2
Failure to Align 2
Labelling, Instructions for Use or Training Problem 2
Biological Environmental Factor 2
Failure to Osseointegrate 2
Peeled / Delaminated 2
Tip 2
Device Damaged by Another Device 2
Failure to Cut 2
Physical Property Issue 2
Sticking 2
Material Separation 2
Tear, Rip or Hole in Device Packaging 1
Crack 1
Dent in Material 1
Mechanical Jam 1
Packaging Problem 1
Positioning Problem 1
Mechanical Problem 1
Misconnection 1
Delivered as Unsterile Product 1
Compatibility Problem 1
Malfunction 1
Device Handling Problem 1
Component or Accessory Incompatibility 1
Disassembly 1
Product Quality Problem 1
Retraction Problem 1
Unstable 1
Structural Problem 1
Difficult or Delayed Positioning 1
Human-Device Interface Problem 1
Physical Resistance / Sticking 1
Material Split, Cut or Torn 1
Positioning Failure 1
Material Discolored 1
Particulates 1
Connection Problem 1
Material Distortion 1
Component Missing 1
Separation Failure 1
Device Difficult to Maintain 1
Total Device Problems 2691

Recalls
Manufacturer Recall Class Date Posted
1 Materialise N.V. II Apr-06-2020
2 Synthes (USA) Products LLC II Jun-07-2016
3 Synthes (USA) Products LLC II Jul-28-2015
4 Zimmer Biomet, Inc. II May-07-2018

-
-