PRECICE PLATING SYSTEM
Received May 26, 2021
Report 3006179046-2021-00287 · MDR key 11888504
Device
Generic name
Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Manufacturer
Nuvasive Specialized Orthopedics, Inc.Model number
LP4.5-SLF40Lot number
0071412
Product problems
- Corroded
- Material Discolored
- Corroded
- Material Discolored
Patient
14 YR
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
DEVICE EVALUATION: VISUAL INSPECTION OF THE RETURNED PLATE REVEALED THAT THE DISTRACTION ROD OF THE PLATE HAD DISCOLORATION WHICH CONFIRMED THE FAILURE MODE. PER THE REPORTED FAILURE FUNCTIONAL TESTING WAS NOT APPLICABLE. THE REPORTED FAILURE MODE IS BEING INVESTIGATED FOR ROOT CAUSE. DEVICE RECORDS REVIEW: A REVIEW OF DEVICE HISTORY RECORDS FOR THE RETURNED UNIT CONFIRMED THAT IT MET ALL THE REQUIRED QUALITY INSPECTIONS PRIOR TO RELEASE.
Description of Event or Problem
NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. THE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN THE EVALUATION HAS BEEN COMPLETED.
Description of Event or Problem
INFORMATION WAS RECEIVED THAT UPON REMOVAL, THE PLATE WAS NOTED TO HAVE DISCOLORATION AND CORROSION.