MAUDE Adverse Event Report: SILONY ROCCIA MULTILIF CAGE 9X34MM, 10 LOR.; ROCCIA MULTILIF CAGE 10X34MM, 10 LOR.; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 1) YDC065P, 2) YDB075P

Device Problem Entrapment of Device (1212)

Patient Problems Foreign Body Reaction (1868); Tissue Breakdown (2681)

Event Type  malfunction  

Event Description

The patient reports had to undergo 5 spinal fusion surgeries.(fusion from l4 to s1).The reasons for the number of surgeries were material failures like broken screws and complications with the bones growing around the screws to stabilize and heal as the bone material degenerated around the screws thus, material intolerance is suspected.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ROCCIA MULTILIF CAGE 9X34MM, 10 LOR.; ROCCIA MULTILIF CAGE 10X34MM, 10 LOR.
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SILONY
• MDR Report Key: 17528661
• MDR Text Key: 321143201
• Report Number: MW5135591
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: 1) YDC065P, 2) YDB075P
• Patient Sequence Number: 1