UNiD_PASS B33225512-07Recalls & reported problems
Medicrea International · UNiD CoCr Rod Ø5.5mm - 07 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03613720268680), received between Aug 10, 2022 and Aug 10, 2022 — classified as 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.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 10, 2022Break; Break
INFORMATION RECEIVED FROM USER FACILITY VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCT. IT WAS REPORTED THAT, THE ROD WAS BROKEN. BASED ON THE POST-OPERATIVE IMAGES THE ROD BROKE IN THE PATIENT SOMETIME AFTER INITIAL UNID SURGERY. AS OF ON (B)(6) 2022, THE BROKEN RODS ARE STILL IN THE PATIENT. THE ORIGINAL UNID SURGERY WAS A REVOISION CASE AS IN, THERE WAS ALREADY PREVIOUS POSTERIOR AND ANTERIOR HARDWARE IN THE PATIENT BEFORE THE UNID RODS WERE IMPLANTED. THE EVENT WAS NOT REPORTED BY A HEALTHCARE PROFESSIONAL, IT WAS CREATED BY UNID LAB ENGINEER BECAUSE THE BROKEN ROD WAS SEEN IN THE POSTOP X-RAYS. PHYSICIAN WAS AWARE OF THE BROKEN UNID ROD, AND THE BROKEN ROD IS STILL CURRENTLY IN THE PATIENT. PHYSICIAN DOES NOT HAVE ANY PLANS OF A REVISION SURGERY TO TAKE THE BROKEN ROD OUT BECAUSE THE PATIENT HAS A FUSION AT THAT LEVEL. PHYSICIAN DID NOT REPORTED ANY PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE EXACT EVENT DATE WAS UNKNOWN, BUT BY LOOKING AT THE POST-OP DATES THE BROKEN ROD OCCURRED BETWEEN 1/7/20 AND 6/2/20. NO FURTHER COMPLICATIONS REPORTED. NO FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15202416 ↗
Other Orthosis, Spinal Pedicle Fixation devices
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- 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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