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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device condylar plate fixation implant
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeJDP
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 124
Adverse Event Without Identified Device or Use Problem 116
Unintended Movement 28
Migration or Expulsion of Device 11
Bent 7
Device-Device Incompatibility 7
Detachment of Device or device Component 6
Insufficient Information 3
Material Deformation 3
Fitting Problem 2
Device Operates Differently Than Expected 2
Corroded 2
Migration 2
Screw 2
Device Dislodged or Dislocated 2
Appropriate Term/Code Not Available 2
No Apparent Adverse Event 1
Failure To Adhere Or Bond 1
Material Integrity Problem 1
Material Twisted / Bent 1
Operating System Becomes Nonfunctional 1
Fracture 1
Device Contamination with Chemical or Other Material 1
Loosening of Implant Not Related to Bone-Ingrowth 1
Crack 1
Mechanical Problem 1
Difficult To Position 1
Total Device Problems 330

Recalls
Manufacturer Recall Class Date Posted
1 Synthes, Inc. II Mar-04-2014

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