MAUDE Adverse Event Report: SEASPINE, INC. MERIDIAN ANTERIOR PLATE SYSTEM, REGATTA LATERAL PLATE SYSTEM; 2 HOLE PLATE

Device Problems Mechanical Problem (1384); Unintended System Motion (1430); Unstable (1667)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

There have been no products, lot numbers or other identifiers provided for evaluation as of the time of this report.The user states that there have been 3 instances of the plate coming loose.Based on the radiograghs provided by the reporter, the issue has been confirmed.The investigation for this case is ongoing.Review of labeling: possible adverse events.Loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.

Event Description

This report is 1 of 3: 3012120772-2021-00060, 3012120772-2021-00061.The surgeon alleges that there have been 3 occurrences of 2-hole plate constructs that have failed, pulling loose from the bone post-op.

• Brand Name: MERIDIAN ANTERIOR PLATE SYSTEM, REGATTA LATERAL PLATE SYSTEM
• Type of Device: 2 HOLE PLATE
• Manufacturer (Section D): SEASPINE, INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drrive; carlsbad CA 92008
• Manufacturer Contact: taara maharaj ; 5770 armada drive; carlsbad, CA 92008 ; 9517042800
• MDR Report Key: 12063523
• MDR Text Key: 261539718
• Report Number: 3012120772-2021-00062
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1