CD HORIZON
Received Jul 30, 2026 · Event occurred Jul 3, 2026
Report 2647346-2026-00414 · MDR key 50083541
Device
Generic name
Appliance, Fixation, Spinal Interlaminal
Manufacturer
Mdt Puerto Rico Operations Co, Med RelModel number
75446535Catalog number
75446535
Lot number
H5881392
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 screw used for Posterior lumbar decompression and internal fixation surgery for pre-operative diagnosis for this procedure L5-S1 intervertebral disc herniation. It was reported that the screw was broken. There were no patient symptoms reported. There were no further complications reported regarding the event.
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.