NextAR Spine Platform 03.57.10.0173Recalls & reported problems
Medacta International SA · NextAR Spine MUST Screwdriver - Short · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 07630345728968), received between Oct 26, 2023 and Jan 19, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2024Fracture; Fracture
DURING NEXTAR SURGERY, THE TIP OF SCREWDRIVER BROKE DURING PEDICLE SCREW 8.0X85MM INSERTION. TAPPING 8.0 WAS PERFORMED INITIALLY. IT TOOK TIME TO RETRIEVE THE BROKEN PIECE FROM THE PEDICLE SCREW HEAD, BUT FINALLY PEDICLE SCREW WAS ABLE TO RETRIEVE. ADDITIONAL TAPPING PERFORMED AND THE SURGERY FINISHED WITH PEDICLE SCREW 8.0X75MM. BACKUP SCREWDRIVER (SAME LOT) SUCCESSFULLY USED. DELAY TIME 40 MIN TO RETRIEVE THE BROKEN PART OF THE SCREWDRIVER AND REVISE THE PEDICLE SCREW. TOTAL SURGERY TIME ABOUT 4 HOURS AND 30 MIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18543116 ↗MalfunctionOct 26, 2023Fracture; Fracture
DURING A NEXTAR CASE, WHILE INSERTING S2AI SCREW (10X100MM), THE TIP OF NEXTAR SPINE MUST SCREWDRIVER - SHORT BROKE. NO SCREW WAS INSERTED IN S2AI AND THE SURGERY WAS COMPLETED SUCCESSFULLY. TAPPING WAS PERFORMED USING REFERENCES 03.51.10.0438 -> 03.51.10.0439 -> 03.51.10.0440. ALL FRAGMENTS WERE REMOVED. DELAY TIME 30 MIN. TOTAL SURGERY TIME 7H. THE DELAY WAS DUE TO THE TIME NECESSARY TO RETRIEVE THE FRAGMENTS OF THE TIP OF SCREWDRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18011498 ↗
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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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