MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE PLATING SYSTEM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number LP4.5-SLF40

Device Problems Unstable (1667); Material Twisted/Bent (2981)

Patient Problem Failure of Implant (1924)

Event Date 09/22/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation as it was not recovered after the removal procedure.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.

Event Description

Information was received that two and a half weeks post-op it was discovered that the plate had disengaged.Additionally, it was reported that there was a slight bend in the plate.No patient adverse event was reported.Report 1 of 2.

• Brand Name: PRECICE PLATING SYSTEM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 12628377
• MDR Text Key: 281081741
• Report Number: 3006179046-2021-00482
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 00887517021267
• UDI-Public: 887517021267
• Combination Product (y/n): N
• PMA/PMN Number: K192181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LP4.5-SLF40
• Device Lot Number: 0071412AAA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR