M.U.S.T. Pedicle Screw System 03.61.324Recalls & reported problems
Medacta International SA · Fenestrated polyax. cann. ped. scr. 6x45,dual-diam · Class 2 · Implant
All models of M.U.S.T. Pedicle Screw System (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030862120), received between Jun 25, 2025 and Nov 13, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- No Apparent Adverse Event1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2025No Apparent Adverse Event; No Apparent Adverse Event
DURING A POSTERIOR SPINAL SURGERY, THE FIRST STEP REDUCER FAILED TO PROPERLY ATTACH TO THE SCREW HEAD. INSPECTION REVEALED THAT A METAL PLATE WAS MISSING FROM THE DISTAL PART OF THE INSTRUMENT. INTRAOPERATIVE FLUOROSCOPY CONFIRMED THAT THE PIECE WAS NOT RETAINED INSIDE THE PATIENT; IT MAY HAVE ALREADY BEEN MISSING PRIOR TO SURGERY. ON THE RIGHT L5 SCREW, THE SECOND STEP REDUCER CAUSED THE SET SCREW TO REPEATEDLY CROSS-THREAD, DAMAGING THE SCREW HEAD THREADS. THIS REDUCER ALSO LOST THE SAME SMALL METAL COMPONENT. AS A RESULT, THE SURGEON REPLACED THE RIGHT L5 SCREW AND BENT THE ROD INTO GREATER LORDOSIS TO PLACE THE SET SCREW WITHOUT A PERSUADER, AS NO FUNCTIONING REDUCTION INSTRUMENT WAS AVAILABLE. SURGERY COMPLETED WITH 30/40 MIN DELAY (TOTAL TIME SURGERY 3 HOURS 10 MINUTES). NO PIECES LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543692 ↗InjuryJun 25, 2025Break; Break
MODIFIED EVENT DESCRIPTION: REVISION SURGERY PERFORMED ABOUT 4 MONTHS AFTER THE PRIMARY SURGERY DUE TO S1 SCREWS BREAKAGE (BELOW THE HEAD). PATIENT WITH GOOD QUALITY BONE, HEAVY PATIENT (AROUND 90KG). NO TRAUMA REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22327510 ↗
Other Bone Cement, Posterior Screw Augmentation devices
- VIPER 186727645Medos International Sàrl · bone cement, posterior screw augmentation3 deaths27 reports
- VIPER 186727745Medos International Sàrl · bone cement, posterior screw augmentation23 reports
- EXPEDIUM VERSE 199723645Medos International Sàrl · bone cement, posterior screw augmentation21 reports
- EXPEDIUM VERSE 199723745Medos International Sàrl · bone cement, posterior screw augmentation13 reports
- VIPER 186727640Medos International Sàrl · bone cement, posterior screw augmentation2 deaths11 reports
- VIPER 186727850Medos International Sàrl · bone cement, posterior screw augmentation9 reports
- EXPEDIUM VERSE 199723435Medos International Sàrl · bone cement, posterior screw augmentation6 reports
- EXPEDIUM VERSE 199723535Medos International Sàrl · bone cement, posterior screw augmentation4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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