PERIMETER¿ System
Received Jul 31, 2026 · Event occurred Jul 8, 2026
Report 3003120897-2026-01316 · MDR key 50096537
Device
Generic name
Intervertebral Fusion Device With Bone Graft,
Manufacturer
Medtronic Sofamor Danek Usa, Inc.Model number
3499002Catalog number
3499002
Lot number
EM19A012
Product problems
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
Information was received from healthcare provider (HCP) via a manufacturer representative regarding a device used in a Spinal therapy. It was reported that, prior to use, the inserter inner sleeves that were broken. There was no patient involved.
Additional Manufacturer Narrative
Medtronic submits this report to comply with FDA regulations 21 CFR Parts 4 and 803. Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by FDA, Medtronic, or its employees that the device, Medtronic, or its employee caused or contributed to the event described in the report. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. Medtronic will submit a supplemental report if additional relevant information becomes known.