Medicrea|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
- 21
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 6 models of Medicrea|UNiD ROD by Medicrea International in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Nov 14, 2023 and Jul 17, 2026 — classified as 4 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Break” (12 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 Medicrea|UNiD ROD problems
Device problems
- Break12
- Fracture7
- Device Handling Problem2
- Adverse Event Without Identified Device or Use Problem1
- Inadequacy of Device Shape and/or Size1
- No Apparent Adverse Event1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Bone Fracture(s)1
Medicrea|UNiD ROD models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Medicrea|UNiD ROD B33125599-02Thoracolumbosacral pedicle screw system6 reports
- Medicrea|UNiD ROD B33126099-02APPLIANCE, FIXATION, SPINAL INTERLAMINAL5 reports
- Medicrea|UNiD ROD B33225599-02APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- Medicrea|UNiD ROD B33226099-02Thoracolumbosacral pedicle screw system4 reports
- Medicrea|UNiD ROD B33226099-01Appliance, fixation, spinal intervertebral body1 report
- Medicrea|UNiD ROD B33244599-01APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
Recent Medicrea|UNiD ROD adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMar 6, 2026Fracture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION THERAPY AT T9 - PELVIS LEVEL. IT WAS REPORTED THAT A ROD FRACTURE OCCURRED AT THE L2-3 LEVEL, AND THE FRACTURED ROD REMAINS IMPLANTED. POSTOPERATIVE X-RAYS WERE CONDUCTED, AND THE ROD FRACTURES WERE IDENTIFIED DURING MEASUREMENT PROTOCOLS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24528425 ↗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 ↗MalfunctionDec 18, 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 PROXIMAL JUNCTIONAL KYPHOSIS ABOVE PRIOR FUSION OF L2-S1. IT WAS REPORTED THAT, SURGEON WAS FUSING T10-PELVIS AND NEEDED TO MAKE ADJUSTMENTS TO THE ROD. INTRA OP CORRECTION WASN¿T ACHIEVED AND NEEDED TO MODIFY BEND TO ACCOMMODATE PATIENT SAGITTAL ALIGNMENT. DURING THE BENDING PROCESS, THE ROD SNAPPED HENCE, SURGEON TOOK A NEW STRAIGHT COCR ROD TO BEND FROM SCRATCH. HE ENDED UP IMPLANTING PART OF THIS UNID ROD AS A SATELLITE ROD IN THE OVERALL CONSTRUCT. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23836328 ↗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 23, 2025Fracture; Fracture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T11 TO THE ILIAC POSTERIOR SPINAL FUSION. IT WAS REPORTED THAT POSTOPERATIVE X-RAYS TAKEN FOR MEASUREMENT PROTOCOLS FOR A CLINIC VISIT ON (B)(6) 2024 REVEALED A RIGHT ROD FRACTURE ABOVE THE L5 SCREW, WITH BOTH RODS STILL IMPLANTED. THE PATIENT HAD INITIAL SURGERY ON (B)(6) 2024. IT WAS UNKNOWN IF SOLID FUSION WAS ACHIEVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23120057 ↗MalfunctionSep 16, 2025Fracture; Fracture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION. IT WAS REPORTED THAT, ROD FRACTURE - RIGHT ROD BETWEEN S1 AND ILIAC SCREW. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FUTURE SURGERY DATE SCHEDULED CURRENTLY TO EXPLANT THE FRACTURED ROD. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23060914 ↗MalfunctionSep 8, 2025Break; Device Handling Problem; Break; Device Handling Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL FUSION. IT WAS REPORTED THAT, THE UNID ROD WAS BROKEN AND THE ROD REMAINS IN PATIENT. LEVELS IMPLANTED WERE T10-ILIAC. THERE WAS NO REVISION SURGERY THAT IS CURRENTLY PLANNED TO EXPLANT THE BROKEN RODS. PATIENT SYMPTOMS WERE ASKED BUT UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22990211 ↗MalfunctionSep 8, 2025Break; Device Handling Problem; Break; Device Handling Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL FUSION. IT WAS REPORTED THAT, THE UNID ROD WAS BROKEN AND THE ROD REMAINS IN PATIENT. LEVELS IMPLANTED WERE T10-ILIAC. THERE WAS NO REVISION SURGERY THAT IS CURRENTLY PLANNED TO EXPLANT THE BROKEN RODS. PATIENT SYMPTOMS WERE ASKED BUT UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22990184 ↗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 ↗MalfunctionJul 7, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A T4-L1 PATIENT HAVING SPINAL TH ERAPY FOR FOR AN INDICATION OF PEDIATRIC DEFORMITY. IT WAS REPORTED THAT THE UNID BROKE INTRA-OPERATIVELY. NO FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22409519 ↗MalfunctionJun 17, 2025Fracture; Fracture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION PROCEDURE FROM T3 TO ILIAC. IT WAS REPORTED THAT DURING POST-OPERATIVE MEASUREMENTS, IT WAS NOTICED THAT THE ROD WAS FRACTURED ABOVE ILIAC SCREWS. THE PATIENT HAD INITIAL SURGERY ON (B)(6) 2024 AND PROVIDED POST-OP X-RAYS FOR A CLINIC VISIT ON (B)(6) 2025 WHICH WERE MEASURED ON (B)(6) 2025. THE RODS REMAINED IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22219459 ↗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 ↗MalfunctionJun 9, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T10-PELVIS POSTERIOR FIXATION AND FUSION PROCEDURE, WITH L2/L5 LAMINECTOMY AND L5/S1 TLIF FOR INDICATION OF STENOSIS, BACK PAIN, AND SAGITTAL IMBALANCE. IT WAS REPORTED THAT THE SURGEON WAS BENDING THE UNID ROD WITH IN SITU BENDERS TO SEAT THE ROD INTO A LOWER LUMBAR SCREW, AND ROD BROKE DURING THIS MANEUVER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22165067 ↗MalfunctionMar 2, 2025Break; Use of Device Problem; Break; Use of Device Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED UNID ROD. PRE-OP DIAGNOSIS OF PATIENT PSF 2 LEVELS ABOVE EXISTING CONSTRUCT. IT WAS REPORTED THAT, LEFT ROD WENT IN FINE, RIGHT ROD BROKE AFTER SURGEON USED IN SITU BENDERS. THERE WAS NO FRAGMENT OF BROKEN ROD LEFT INSIDE PATIENT BODY. THE LEVELS PLANNED FOR IMPLANTATION WERE T2-PELVIS. THE SURGEON BENT THE ROD IN SITU WHICH IS ACTUALLY AGAINST IFU LABELING SO THEY DID NOT USE THE RODS ACCORDING TO IFU LABELING. THERE WAS NO MANUFACTURING ISSUE ASSOCIATED WITH REPORTED UNID ROD. THERE WERE NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR COMPLICATIONS REPORTED. NO FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21500909 ↗
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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