UNiD ROD B33225512-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03613720268635), received between Dec 6, 2021 and Dec 29, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Fracture; Fracture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION THERAPY AT T10-ILIAC. THE PRE-OPERATIVE DIAGNOSIS INDICATED THAT POSTERIOR FUSION WAS NEEDED IT WAS REPORTED THAT POSTOPERATIVE X-RAYS REVEALED ROD FRACTURES ABOVE L5, WITH THE ROD FRAGMENT REMAINING IMPLANTED IN THE PATIENT. THE ROD WAS CONFIRMED TO HAVE FRACTURED AND A FRAGMENT IS STILL PRESENT IN THE PATIENT. RADIOGRAPHIC IMAGING WAS PERFORMED AND MEASURED, WHICH IDENTIFIED THE ROD FRACTURES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23905500 ↗
• MalfunctionNov 27, 2025Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED STATING THERE WAS NO PLANS TO REVISE THE PATIENT, NO PATIENT SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663894 ↗
• InjuryMar 27, 2025Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REVISION POSTER IOR SPINAL FUSION AND POSTERIOR SPINAL INSTRUMENTATION T11 TO THE PELVIS. PRE-OP DIAGNOSIS: BILATERAL L4-5 FORAMINAL STENOSIS (STABLE COMPARED TO MARCH CT), RIGHT L5-S1 FORAMINAL STENOSIS (ALSO STABLE COMPARED TO (B)(6)) AND BILATERAL SI JOINT ARTHRITIS. IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY ON (B)(6) 2023 AND EXPERIENCED LOW BACK PAIN AND LEG PAIN POST-OPERATIVELY, RIGHT GREATER THAN LEFT. THE UNID ROD WAS FRACTURED AT THE LEVEL OF THE S1 SCREW ON THE LEFT SIDE AND THE RIGHT ILIAC SCREW WAS FRACTURED. IT IS UNKNOWN IF THE SCREWS ARE OF MEDTRONIC PRODUCTS. THERE IS A POSSIBILITY OF BROKEN HARDWARE STRESSING THE BONE. THE PATIENT IS SCHEDULED FOR A REVISION SURGERY ON (B)(6) 2025 DUE TO LOW BACK PAIN AND ROD FRACTURE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 21705744 ↗
• MalfunctionFeb 24, 2025Break; Break

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF A PATIENT UNDERGOING POSTERIOR AND LATERAL SPINAL FUSION. THE PRE-OP DIAGNOSIS WAS ADULT SCOLIOSIS. IT WAS REPORTED THAT, ONE OF THE UNID ROD WAS BROKEN WHEN TRIED TO BEND THE ROD WITH FRENCH BENDER. THE ROD WAS BROKEN OUTSIDE THE PATIENT BODY. THE UNID RODS WERE 5.5 COCR, AND THE BROKEN ROD WAS NOT IMPLANTED. THE PLAN WAS TO FUSE PATIENT¿S VERTEBRAE FROM T10-PELVIS BY IMPLANTING LATERAL LUMBAR INTERBODY FUSION CAGES L2-L5. THERE WERE NO FRAGMENTS OF BROKEN ROD WERE LEFT INSIDE THE PATIENT BODY. SURGEON DIDN¿T DO ENOUGH BONE WORK TO LOOSEN UP THE SPINE SO THE ROD WOULD FIT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444607 ↗
• MalfunctionSep 11, 2024Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE ROD WAS FRACTURED POST-OPERATIVELY. IT REMAINS IMPLANTED IN PATIENT. IT WAS UNKNOWN, IF SURGEON IS AWARE OF SECOND ROD FRACTURE. PROCEDURE/TECHNIQUE PERFORMED WAS SPINAL FUSION. THE SYMPTOMS TO THE PATIENT WERE ASKED BUT UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20188171 ↗
• MalfunctionMay 2, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED UNID ROD. IT WAS REPORTED THAT, THE UNID ROD WAS FRACTURED. IT WAS UNKNOWN IF SURGEON IS AWARE OF ROD FRACTURE. MEDTRONIC TEAM NOTICED FRACTURE DURING MEASURING THE POST OP X-RAY. THE ROD REMAINS IMPLANTED IN PATIENT. IT WAS UNKNOWN, IF THE PATIENT EXPERIENCED ANY SYMPTOMS AS A RESULT.  NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19227963 ↗
• MalfunctionSep 22, 2023Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED. NO PATIENT ISSUES AND NO REVISION SURGERY PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17797016 ↗
• MalfunctionNov 22, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T4-PELVIS POSTE RIOR FUSION WITH TLIF L5-S1. IT WAS REPORTED THAT IN-SITU BENT ROD THEN TRIED TO MEET THE ROD TO THE SPINE AND IT BROKE UNDER THE PRESSURE. 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 15841418 ↗
• InjuryDec 6, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION FROM T4 TO THE PELVIS WITH S2AI SCREWS USING UNID RODS FOR ALIF L5-S1 (30 DEG LORDOTIC GRAFT), SPO L2-3. IT WAS REPORTED THAT THE UNID ROD BROKE AROUND L4-L5 REGION. DUE TO BROKEN ROD THERE WAS LOOSENING OF THE ALIF IMPLANT AT L5-S1. THE ROD ALSO LOST SOME OF ITS BEND OVERTIME AND THE PATIENT HAD LOST SOME CORRECTION. FROM PATIENT'S X-RAYS IT CAN BE OBSERVED THAT THE ROD HAS BEEN REPLACED AND THE SURGEON ADDED AN EXTRA FIXTURE TO SECURE/ STABILIZE THE PATIENT. REVISION SURGERY WAS SUCCESSFULLY COMPLETED ON (B)(6) 2021 WITHOUT ANY COMPLICATIONS. BOTH RODS WERE BROKEN BETWEEN L5 AND S1 AND THEY WERE COMPLETELY EXPLANTED AND REPLACED WITH NEW ONES. 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 12932122 ↗