Medicrea|UNiD ROD B33125599-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03613720289494), received between Feb 24, 2025 and Jul 17, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2026Inadequacy of Device Shape and/or Size

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25853557 ↗
• MalfunctionFeb 5, 2026Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, POSTOPERATIVE X-RAYS WERE MEASURED AND NOTICED THE ROD FRACTURES DURING MEASUREMENT PROTOCOLS. PROCEDURE PERFORMED WAS POSTERIOR SPINAL FUSION AT LEVELS L2-S1. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24266363 ↗
• InjuryDec 8, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  SUBSEQUENT TO SUBMISSION OF THE INITIAL MDR, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DEVICE INVOLVED WAS NOT MANUFACTURED BY MEDTRONIC. THE INITIAL REPORT WAS SUBMITTED BASED ON PRELIMINARY INFORMATION. NO MEDTRONIC DEVICE FAILURE IS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23739664 ↗
• MalfunctionSep 2, 2025Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. THE PATIENT WAS HAVING POSTERIOR SPINAL FUSION PROCEDURE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936692 ↗
• MalfunctionJun 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS DEGENERATIVE SPINE, STENOSIS, SCOLIOSIS. IT WAS REPORTED THAT, THE UNID ROD WAS BROKEN. THE UNID ROD BROKE ABOVE THE RIGHT S2 SCREW. THE SMALL FRAGMENT THAT WAS IN S2 WAS REMOVED. THE REMAINING ROD FROM T10-S1 REMAINS IN THE PATIENT AND A LATERAL CONNECTOR AND DOMINOS WERE USED TO AFFIX A SUPPLEMENTAL ROD AND THE S2 SCREW TO THE REMAINDER OF THE CONSTRUCT. PROCEDURE PERFORMED WAS T10-PELVIS, L2/3 DIRECT LATERAL LUMBAR FUSION, L3/4 AND L4/L5 TRANSFORAMINAL LUMBAR INTERBODY FUSION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182218 ↗
• InjuryFeb 24, 2025Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T10-PELVIS POST ERIOR SACROILIAC FUSION (PSIF). IT WAS REPORTED THAT THE ROD WAS FRACTURED POST-OPERATIVELY AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 TO EXPLANT THE BROKEN ROD. THE BROKEN ROD WAS REPLACED IN REVISION SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21443650 ↗