Spine Instruments 03.75.10.0060Recalls & reported problems
Medacta International SA · Rod reduction device · Class 1
All models of Spine Instruments (28)
Data updated Oct 16, 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 07630971208872), received between Sep 27, 2019 and Nov 8, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Insert1
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.
MalfunctionNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING C2-T5 SPINAL FIXATION SURGERY, AT C7 LEVEL, DURING THE ROD REDUCTION PROCEDURE, THE MUST MINI REDUCTION DEVICE - SHORT AND ROD REDUCTION DEVICES WERE DISENGAGED FROM THE PEDICLE SCREW. THE REDUCTION DISTANCE TO PERFORM WAS ABOUT 3 MM. THE SURGEON PERFORMED THE ROD BENDING AGAIN AND COMPLETED THE SURGERY WITHOUT USING THE REDUCTION DEVICES. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 1 HOUR. TOTAL SURGERY TIME WAS ABOUT 5 HOURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18091465 ↗MalfunctionSep 27, 2019Difficult to Insert
SPINAL FIXATION PERFORMED AT C2-T1. AFTER THE INSERTION OF THE ROD, THE SURGEON TRIED TO USE THE ROD REDUCTION DEVICE BECAUSE THE RODS WERE NOT INSERTED COMPLETELY INTO THE PEDICLE SCREW HEADS AT BOTH SIDE OF C5. WHEN THE SURGEON GRIPPED THE HANDLE OF THE ROD REDUCTION DEVICE, THE ROD REDUCTION DEVICE EASILY DISENGAGED FROM THE PEDICLE SCREW HEAD. THE SURGEON WAS NOT ABLE TO INSERT THE ROD BECAUSE THE SAME EVENT RECURRENTED MANY TIMES. THE SURGEON DISENGAGED THE ROD AND PERFORM THE ROD BENDING AGAIN AND FINISHED THE SURGERY WITHOUT USING THE ROD REDUCTION DEVICE. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 30 MINUTES. TOTAL SURGERY TIME WAS ABOUT 5 HOURS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9128862 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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