M.U.S.T. Rods 03.50.433Recalls & reported problems
Medacta International SA · Rod CoCr 5.5 x 480mm Sterile · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030835445), received between Jul 13, 2018 and Jul 29, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (1 report).
1 other recall cover devices cleared under the same FDA submission (K121115); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Blood Loss1
- 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.
InjuryJul 29, 2019Adverse Event Without Identified Device or Use Problem
REVISION SURGERY 2 DAYS AFTER PRIMARY. FROM POST OPERATIVE X-RAYS THE SURGEON WAS NOT SATISFIED OF THE ROD CURVATURE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8836608 ↗InjuryJul 13, 2018Break
THE ROD SNAPPED INSIDE THE PATIENT. IT IS UNKNOWN HOW THE ROD SNAPPED. IT IS UNKNOWN WHEN THE REVISION WILL TAKE PLACE. THE SURGEON DID NOT PERFORM AN OSTEOTOMY. THE PATIENT HAD SIGNIFICANT BLOOD LOSS AND THIS WAS THEIR 3RD SURGERY. THAT MAY HAVE FACTORED INTO THAT DECISION. NO CAGE SUBSIDENCE OR FRACTURE WAS MENTIONED. PATIENT WILL BE REVISED WITH COMPETITOR'S IMPLANTS.
Patient problems: Blood Loss
MAUDE report 7685636 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K121115. One submission often covers many models, so check the product and lot details in each record.
- Z-1023-2017 · Dec 7, 2016 · TerminatedMedacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to
Other Orthosis, Spinal Pedicle Fixation devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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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