UNiD ROD B33125512-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03613720268468), received between Aug 29, 2023 and Feb 24, 2025 — classified as 3 injuries, 3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 PLANNED ON (B)(6) 2025 TO EXPLANT THE BROKEN ROD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21443636 ↗
• MalfunctionJan 30, 2025Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T10-ILEUM SPINAL FUSION FOR AN INDICATION OF FLAT BACK SYNDROME, RADICULAR PAIN, POST SURGICAL ARTHROSIS AND LOW BACK PAIN. IT WAS REPORTED THAT DURING MEASURING THE POST OP X-RAY, IT WAS NOTICED THAT THE ROD WAS FRACTURED. 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 21271600 ↗
• MalfunctionSep 23, 2024Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T10-PELVIS POST ERIOR SPINAL FUSION WITH A PSO FOR AN INDICATION OF ADJACENT SEGMENT STENOSIS/DDD AND SEVERE SAGITTAL IMBALANCE. IT WAS REPORTED THAT THE RODS APPEAR TO HAVE FRACTURED AROUND THE S1 SCREWS. THE POSTOP XRAY WAS FROM (B)(6) 2023, BUT THE ROD FRACTURE WAS IDENTIFIED WHILE MEASURING THE POSTOP IMAGES ON (B)(6) 2024. THERE WERE NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20276716 ↗
• InjuryApr 12, 2024Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T10-PELVIS PSIF FOR AN INDICATION OF STAGE I L1-S1 ATP, STAGE II T10-PELVIS FUSION WITH L1/2, L2/3 AND L5/S1 PONTE. IT WAS REPORTED THAT THE L5-S1 UNFUSED AND THE ROD HAS FRACTURED. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2024. 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 19094603 ↗
• InjuryJan 18, 2024Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T10-PELVIS FUSI ON, L4 PSO AND L4-S1 TLIF. IT WAS REPORTED THAT THE ROD FRACTURED AT L4/5 (PSO PERFORMED AT L4) POSTOPERATIVELY. USAGE STATES: ADDED A BIT OF LORDOSIS AT L4-S1 AND BENT ROD A BIT IN CORONAL PLANE AS WELL TO ACCOMMODATE THE SPINE, BUT NO EXCESSIVE FORCE WAS USED IN THE OR. 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 18532855 ↗
• MalfunctionAug 29, 2023Break; 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 PATIENT'S POST OP FROM (B)(6) 2023 (1YEAR) REVEALED A ROD BREAKAGE AROUND THE L5-S1 LEVEL. ONLY ONE ROD APPEARS BROKEN, AND THERE ARE NO ADDITIONAL POST OPS AVAILABLE TO DETERMINE IF THE ROD HAS BEEN REPLACED OR STILL IS IMPLANTED AFTER (B)(6) 2023. PROCEDURE OR TECHNIQUE PERFORMED WAS T10-PELVIS DECOMPRESSION/FUSION WITH LUMBAR OSTEOTOMIES, TLIFS, SI FIXATION. IT WAS UNKNOWN ABOUT THE PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640311 ↗