UNiD RODRecalls & reported problems across all models
Medicrea International · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 6 models of UNiD ROD by Medicrea International in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2021 and Dec 29, 2025 — classified as 9 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Fracture” (16 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported UNiD ROD problems
Device problems
- Fracture16
- Break9
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Pain2
- Foreign Body In Patient1
- Seroma1
UNiD ROD models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- UNiD ROD B33225512-02Orthosis, Spinal Pedicle Fixation9 reports
- UNiD ROD B33125512-02Orthosis, Spinal Pedicle Fixation6 reports
- UNiD ROD B33126012-02Orthosis, Spinal Pedicle Fixation6 reports
- UNiD ROD B33226012-02Orthosis, Spinal Pedicle Fixation3 reports
- UNiD ROD B33126012-01Orthosis, Spinal Pedicle Fixation1 report
- UNID ROD B33245600-01Orthosis, Spinal Pedicle Fixation1 report
Recent UNiD ROD adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJun 26, 2025Fracture; Fracture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE UNID ROD WAS FRACTURED. POSTOPERATIVE X-RAYS WERE MEASURED AND FOUND THAT THE ROD WAS FRACTURED IN LUMBAR LEVEL. PROCEDURE PERFORMED WAS POSTERIOR SPINAL FUSION. LEVELS IMPLANTED WERE T4-ILIAC BONE. IT WAS UNKNOWN ABOUT THE PATIENT SYMPTOMS OR COMPLICATIONS. NO FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22334779 ↗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 ↗MalfunctionMar 4, 2025Fracture; Fracture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4-PELVIS POSTE RIOR SPINAL FUSION. IT WAS REPORTED THAT DURING A POSTOPERATIVE EVALUATION, ROD FRACTURES WERE IDENTIFIED ABOVE THE S1 SCREWS. BOTH RODS REMAINED IMPLANTED IN THE PATIENT. POSTOPERATIVE X-RAYS CONFIRMED THE PRESENCE OF ROD FRACTURES. RADIOGRAPHIC IMAGES WERE AVAILABLE FOR REVIEW. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21512613 ↗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 ↗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 ↗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 ↗MalfunctionJul 17, 2024Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS SPINAL DEFORMITY. IT WAS REPORTED THAT, ROD BREAKAGE SEEN IN POSTOP IMAGING. THE LEVELS IMPLANTED WERE L1-S1. PROCEDURE/TECHNIQUE PERFORMED WAS POSTERIOR SPINAL 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 19760044 ↗MalfunctionJul 15, 2024Fracture; Fracture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE RODS WERE NOTICED BROKEN JUST ABOVE THE L3 PEDICLE SCREW ON A POST-OPERATIVE X-RAY. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19739121 ↗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 ↗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 ↗
Other Medicrea International products
All Medicrea International devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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