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MySpine 7.0704Recalls & reported problems

Medacta International SA · MySpine-MC vertebra L04 · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040717298), received between Jul 6, 2018 and Feb 18, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Inadequacy of Device Shape and/or Size1
  • Material Protrusion/Extrusion1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 18, 2021Inadequacy of Device Shape and/or Size

    SPINAL FIXTAION WAS PERFORMED AT L4-S2 WITH MYSPINE GUIDES. THE SURGEON WAS NOT ABLE TO SET THE MYSPINE GUIDE L4 AND L5 ON THE PATIENT BONE BECAUSE THE BONE MODEL WAS COMPLETELY DIFFERENT FROM THE PATIENT BONE. THE SURGEON INSERTED THE PEDICLE SCREW AT L4-L5 WITHOUT USING THE MYSPINE GUIDE. THE SURGEON WAS DIFFICULT TO SET THE MYSPINE GUIDE S1 AND S2 ON THE PATIENT BONE BECAUSE THE SLEEVE WAS DESIGNED INTO THE HOLE. IT WAS HARD TO CONFIRM IF THE GUIDE WAS CORRECTLY SET ON DURING THE SURGERY. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 1 HOUR. TOTAL SURGERY TIME WAS ABOUT 5 HOURS. THE SURGEON EXPRESSED AN OPINION THAT HE FELT THE MYSPINE ACCURACY BECAME LOWER THAN IN THE PAST. L5 OSTEOTOMY WAS PERFORMED ACCORDING TO PLANNING BUT THE PATIENT BONE SHAPE AND THE BONE MODEL SHAPE WERE SIGNIFICANTLY DIFFERENT. THE SURGEON FELT THAT THE BONE MODEL WERE RECECTED TOO MUCH.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11341872 ↗
  • MalfunctionJul 6, 2018Material Protrusion/Extrusion

    THE SURGERY WAS PERFORMED ON (B)(6) WITH MYSPINE MC GUIDE. WHEN THE SURGEON CHECKED THE CT IMAGE ON (B)(6), HE NOTICED THAT THE PEDICLE SCREWS WERE INSERTED IN A DIFFERENT PLACE IN COMPARISON WITH THE PLANNING. ONE OF THE PEDICLE SCREW PROTRUDES LATERALLY AND THE OTHER ONE MEDIALLY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7666246 ↗

Other Pedicle Screw Placement Guide devices

All Pedicle Screw Placement Guide devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.