UNKNOWN
Received Jul 6, 2026 · Event occurred Jun 11, 2026
Report 3003120897-2026-01162 · MDR key 25713639
Device
Generic name
Thoracolumbosacral Pedicle Screw System
Manufacturer
Medtronic Sofamor Danek Usa, Inc.Model number
MSB_UNK_SET SCREWCatalog number
MSB_UNK_SET SCREW
Lot number
UNKNOWN
Product problems
- Device Dislodged or Dislocated
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Description of Event or Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REOPERATION C1/2 POSTERIOR FIXATION, BONE GRAFTING FOR C1 INSTABILITY DUE TO TRAUMA. IT WAS REPORTED THAT PATIENT HAD POSTOPERATIVE SET-SCREW DISLODGEMENT. THE RIGHT C1 SET SCREW DISENGAGED POSTOPERATIVELY, AND LOOSENING OF THE RIGHT SCREW (C1/2) WAS CONFIRMED; THEREFORE, THE SIZE WAS CHANGED AND REFIXATION WAS PERFORMED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.