CorteraRecalls & reported problems across all models
Xtant Medical Holdings, Inc. · 7 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Cortera model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 2
We found 7 models of Cortera by Xtant Medical Holdings, Inc. in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Jun 3, 2024 and Aug 11, 2026 — classified as 2 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
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
Cortera recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 21, 2024Class IIOpen, Classified
Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.
Z-0125-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Nov 28, 2023Class IIOpen, Classified
Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.
Z-0846-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported Cortera problems
Device problems
- Break3
- Deformation Due to Compressive Stress1
- Device Misassembled During Manufacturing /Shipping1
- Fracture1
- Labelling, Instructions for Use or Training Problem1
- Material Deformation1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Pain2
Cortera models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Cortera 150100-65045Thoracolumbosacral pedicle screw system1 recall2 reports
- Cortera 150100-85050Thoracolumbosacral pedicle screw system1 recall0 reports
- Cortera 150103-65045Thoracolumbosacral pedicle screw system2 reports
- Cortera 150100-75050Thoracolumbosacral pedicle screw system1 report
- Cortera 150100-75055Thoracolumbosacral pedicle screw system1 report
- Cortera 150150-65040Thoracolumbosacral pedicle screw system1 report
- Cortera 1505-000120Orthopedic manual surgical instrument1 report
Recent Cortera adverse event reports
The 8 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50213525 ↗MalfunctionJun 4, 2026No Apparent Adverse Event
THE MANUFACTURER WAS MADE AWARE OF TWO 90 IN-LB TORQUE-LIMITING HANDLES THAT WERE REQUESTED TO BE REPLACED AND VERIFIED FOR TORQUE-LIMITING CALIBRATION. THE RETURNED TORQUE LIMITING HANDLES WERE TESTED AND WERE FOUND TO BE WITHIN SPECIFICATION. ADDITIONALLY, AN X-RAY IMAGE WAS PROVIDED WITH THE COMPLAINT; HOWEVER, NO CONTEXT WAS PROVIDED WITH THE IMAGE AND THERE WAS NO IDENTIFYING INFORMATION LINKING THE IMAGE TO THE TORQUE-LIMITING HANDLES. THERE WERE NO REPORTED PATIENT INJURIES OR DELAYS IN SURGERY ASSOCIATED WITH THE COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25393493 ↗MalfunctionFeb 18, 2026Break; Material Deformation
A FOLLOW-UP REPORT TO 3005031160-2026-00005 SUBMITTED ON 02/18/2026 IS BEING SUBMITTED AS THE MANUFACTURER HAS COMPLETED INVESTIGATION ACTIVITIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24378482 ↗MalfunctionOct 3, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR FUSION AFTER PERFORMING A L5-1 ALIF ON (B)(6) 2024. DURING THE PROCEDURE, THE TULIP/TOWER OF THE SCREW DISSOCIATED FROM THE SCREW SHAFT DURING INSERTION OF THE SCREW, POSSIBLY WITH BONEY CONTACT NEARING FULL SEATING. THE SCREW SHAFT WAS REMOVED, AND A NEW SCREW WAS INSERTED WITHOUT FURTHER ISSUE AND NO NOTED DELAY IN SURGERY. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20360396 ↗MalfunctionSep 18, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL FIXATION SURGERY INVOLVING THE PEDICLE SCREW SYSTEM. DURING THE SURGERY IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY WITH SITTING THE ROD INTO THE SCREW. NO PATIENT COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20246892 ↗MalfunctionSep 12, 2024Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
IT WAS REPORTED THAT A PEDICLE SCREW WITH DNI IMPRINTED ON THE SCREW TULIP WAS IMPLANTED. THE SCREW DID NOT LOCK DOWN AND WAS REMOVED AND REPLACED WITH A CLINICAL CORTERA SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20206255 ↗InjuryJun 3, 2024Break; Break
IT WAS REPORTED THAT, DURING A POST-OPERATIVE VISIT DUE TO THE ONSET OF BACK PAIN AT AN ADJACENT LEVEL THAT WAS NOTED TO BE UNRELATED TO THE EXISTING POSTERIOR FIXATION CONSTRUCT, IT WAS IDENTIFIED THAT BOTH PEDICLE SCREWS AT S1 HAD BROKEN. A REVISION PROCEDURE WAS PERFORMED APPROXIMATELY ONE YEAR AFTER THE INITIAL IMPLANTATION IN WHICH THE MALFUNCTIONED SCREWS WERE REMOVED, AND THE REMAINING IMPLANT CONSTRUCT WAS EXTENDED TO L3. THE PATIENT WAS REPORTED TO BE IN GOOD HEALTH STATUS WITH NO ADDITIONAL PROCEDURES PLANNED OR REQUIRED. AN RMA# WAS ISSUED FOR RETURN OF THE EXPLANTED DEVICES, WHICH WERE RECEIVED AT THE MANUFACTURER FOR ASSESSMENT.
Patient problems: Pain
MAUDE report 19455984 ↗InjuryJun 3, 2024Break; Break
IT WAS REPORTED THAT, DURING A POST-OPERATIVE VISIT DUE TO THE ONSET OF BACK PAIN AT AN ADJACENT LEVEL THAT WAS NOTED TO BE UNRELATED TO THE EXISTING POSTERIOR FIXATION CONSTRUCT, IT WAS IDENTIFIED THAT BOTH PEDICLE SCREWS AT S1 HAD BROKEN. A REVISION PROCEDURE WAS PERFORMED APPROXIMATELY ONE YEAR AFTER THE INITIAL IMPLANTATION IN WHICH THE MALFUNCTIONED SCREWS WERE REMOVED, AND THE REMAINING IMPLANT CONSTRUCT WAS EXTENDED TO L3. THE PATIENT WAS REPORTED TO BE IN GOOD HEALTH STATUS WITH NO ADDITIONAL PROCEDURES PLANNED OR REQUIRED. AN RMA# WAS ISSUED FOR RETURN OF THE EXPLANTED DEVICES, WHICH WERE RECEIVED AT THE MANUFACTURER FOR ASSESSMENT.
Patient problems: Pain
MAUDE report 19455982 ↗
Other Xtant Medical Holdings, Inc. products
All Xtant Medical Holdings, Inc. 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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