VERTEX Reconstruction SystemRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 34 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 106
- Deaths reported
- 0
- Injuries reported
- 37
- Recalls
- 1
We found 34 models of VERTEX Reconstruction System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 106 adverse event reports in the FDA's MAUDE database, received between Mar 21, 2017 and Sep 24, 2026 — classified as 37 injuries, 69 malfunctions.
The most frequently reported specific device problem is “Break” (40 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
VERTEX Reconstruction System 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.
- Mar 26, 2020Terminated
Nonconforming product; length of the product measured shorter than the labeled length.
Z-1941-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported VERTEX Reconstruction System problems
Device problems
- Break40
- Device Slipped17
- Failure to Align11
- Adverse Event Without Identified Device or Use Problem8
- Material Deformation7
- Detachment of Device or Device Component5
- Loosening of Implant Not Related to Bone-Ingrowth5
- Migration or Expulsion of Device5
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- No Known Impact Or Consequence To Patient36
- No Consequences Or Impact To Patient8
- Post Operative Wound Infection6
- Failure of Implant4
- Nerve Damage4
- Pain4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
VERTEX Reconstruction System models
34 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VERTEX® Reconstruction System 6958838APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 recall0 reports
- VERTEX® Reconstruction System 6950315APPLIANCE, FIXATION, SPINAL INTERLAMINAL36 reports
- VERTEX® Reconstruction System 7753500APPLIANCE, FIXATION, SPINAL INTERLAMINAL12 reports
- VERTEX® Reconstruction System 7752529APPLIANCE, FIXATION, SPINAL INTERLAMINAL8 reports
- VERTEX® Reconstruction System 6900240APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- VERTEX® Reconstruction System 6958724APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- VERTEX® Reconstruction System 6958714APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- VERTEX® Reconstruction System 7755124APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- VERTEX® Reconstruction System G7755124ORTHOSIS, SPINAL PEDICLE FIXATION3 reports
- VERTEX® Reconstruction System 7002527APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- VERTEX® Reconstruction System 7750346APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- VERTEX® Reconstruction System 7752526APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- VERTEX® Reconstruction System 7755122APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- VERTEX® Reconstruction System 6958814APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- VERTEX® Reconstruction System 6958726APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- Vertex Reconstruction System G7755275APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- VERTEX® Reconstruction System 7002526APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- VERTEX® Reconstruction System 7752536APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- VERTEX® Reconstruction System 6958924APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- VERTEX® Reconstruction System 6958824APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- VERTEX® Reconstruction System 6958734APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- VERTEX® Reconstruction System 6958718APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- VERTEX® Reconstruction System 6958716APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- VERTEX® Reconstruction System 6958712APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- VERTEX® Reconstruction System 6958734PTAPPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- VERTEX® Reconstruction System 7755278APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- VERTEX® Reconstruction System 7753520APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- VERTEX® Reconstruction System 7750445APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- VERTEX® Reconstruction System 7751101APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- VERTEX® Reconstruction System G7755271APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- VERTEX® Reconstruction System 7752524APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- VERTEX® Reconstruction System 7753707APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- VERTEX® Reconstruction System 6900120APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- VERTEX® Reconstruction System 6955506APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
Recent VERTEX Reconstruction System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Nonstandard Device
Information was received from multiple sources (Healthcare professional, Distributor) regarding a Screw used for Pedicle screw fixation surgery with transforaminal lumbar interbody fusion therapy. It was reported that, prior to a pedicle screw fixation surgery with transforaminal lumbar interbody fusion, a Medtronic MAS screw was identified as having a screw head defect in which the distance between the two wings of the screw head was narrower than normal. It was reported that the inner set screw could not be inserted properly and the rod could not be securely locked in place. There was no patient involvement reported. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50878875 ↗MalfunctionSep 7, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50645253 ↗MalfunctionFeb 3, 2026Mechanical Problem; Material Deformation
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR CERVI CAL DECOMPRESSION AND INTERNAL FIXATION SPINAL THERAPY FOR POSTERIOR CERVICAL SPINAL STENOSIS. IT WAS REPORTED THAT WHEN THE SURGEON WAS IMPLANTING THE SCREW NUT, HE FOUND THAT IT COULD NOT BE TIGHTENED AND OCCURRED SLIPPERY THREAD, INDICATING THAT THE SCREW NUT HAD STRIPPED. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE THREAD SLIPPAGE OCCURRED DURING NORMAL USAGE OF DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24243788 ↗MalfunctionNov 3, 2025Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR CERVI CAL INTERBODY FUSION DUE TO CERVICAL SPINE TUMOR. IT WAS REPORTED THAT SET SCREW THREAD WAS SLIPPERY AND RESULTING IN THE SET SCREW BEING UNABLE TO BE IMPLANTED NORMALLY. 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 23452267 ↗MalfunctionMay 26, 2025Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING SPINAL TU RESUTURING. IT WAS REPORTED THAT 1 LATERAL MASS SCREW BLOCKER WAS DAMAGED DURING SURGERY, IT BROKE DURING PLACEMENT. 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 22082965 ↗InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION WAS RECEIVED FROM REGULATORY BODY (RB), HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING PRODUCT USED FOR ROBOT-ASSISTED SKULL TRACTION POSTERIOR CERVICAL APPROACH ATLANTOAXIAL REDUCTION AND INTERNAL FIXATION WAS PERFORMED FOR TREATMENT OF AXIS FRACTURE. IT WAS REPORTED THAT AFTER THE OPERATION, WOUND INFECTION OCCURRED ON (B)(6)2024. DEBRIDEMENT, PERFUSION, FLUSHING AND DRAINAGE OPERATION WAS PERFORMED ON (B)(6)2024. THE CAUSE OF INFECTION WAS DUE TO PATIENT'S CONDITION. THERE WAS NO DEVICE MALFUNCTION REPORTED AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WAS NO MALFUNCTION WITH REPORTED PRODUCTS AND THEY ARE NOT EXPLANTED, STILL REMAINS IN PATIENT.
Patient problems: Post Operative Wound Infection
MAUDE report 21524310 ↗InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION WAS RECEIVED FROM REGULATORY BODY (RB), HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING PRODUCT USED FOR ROBOT-ASSISTED SKULL TRACTION POSTERIOR CERVICAL APPROACH ATLANTOAXIAL REDUCTION AND INTERNAL FIXATION WAS PERFORMED FOR TREATMENT OF AXIS FRACTURE. IT WAS REPORTED THAT AFTER THE OPERATION, WOUND INFECTION OCCURRED ON (B)(6) 2024. DEBRIDEMENT, PERFUSION, FLUSHING AND DRAINAGE OPERATION WAS PERFORMED ON (B)(6) 2024. THE CAUSE OF INFECTION WAS DUE TO PATIENT'S CONDITION. THERE WAS NO DEVICE MALFUNCTION REPORTED AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WAS NO MALFUNCTION WITH REPORTED PRODUCTS AND THEY ARE NOT EXPLANTED, STILL REMAINS IN PATIENT.
Patient problems: Post Operative Wound Infection
MAUDE report 21524281 ↗InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION WAS RECEIVED FROM REGULATORY BODY (RB), HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING PRODUCT USED FOR ROBOT-ASSISTED SKULL TRACTION POSTERIOR CERVICAL APPROACH ATLANTOAXIAL REDUCTION AND INTERNAL FIXATION WAS PERFORMED FOR TREATMENT OF AXIS FRACTURE. IT WAS REPORTED THAT AFTER THE OPERATION, WOUND INFECTION OCCURRED ON (B)(6) 2024. DEBRIDEMENT, PERFUSION, FLUSHING AND DRAINAGE OPERATION WAS PERFORMED ON (B)(6) 2024. THE CAUSE OF INFECTION WAS DUE TO PATIENT'S CONDITION. THERE WAS NO DEVICE MALFUNCTION REPORTED AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WAS NO MALFUNCTION WITH REPORTED PRODUCTS AND THEY ARE NOT EXPLANTED, STILL REMAINS IN PATIENT.
Patient problems: Post Operative Wound Infection
MAUDE report 21524255 ↗MalfunctionMar 4, 2025Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN OPEN DECOMPRESSION AND INTERNAL FIXATION PROCEDURE IN A PATIENT DIAGNOSED WITH POSTERIOR CERVICAL SPINAL STENOSIS. IT WAS REPORTED THAT THE SCREW THREAD WAS DAMAGED DURING THE SCREWING PROCESS AND COULDN'T BE USED ANY FURTHER. 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 21512509 ↗MalfunctionJan 30, 2025Break; Break
INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE VIA A HEALTHCARE PROFESSIONAL REGARDING A PATIENT IMPLANTED WITH SCREW. IT WAS REPORTED THAT DURING A POSTERIOR CERVICAL INCISION, DECOMPRESSION, REDUCTION, AND INTERNAL FIXATION PROCEDURE, A SCREW BROKE. THE PROCEDURE WAS CONDUCTED TO ADDRESS CERVICAL POSTERIOR SPINAL CANAL STENOSIS. THE BROKEN PRODUCT WAS SUBSEQUENTLY EXPLANTED AND THE PRODUCT WAS REPLACED. WHEN THE SCREW WAS BEING INSTALLED, THE U-SHAPED PART OF THE SCREW BROKE AND BECAME DEFECTIVE. 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 21271919 ↗MalfunctionDec 30, 2024Mechanics Altered; Mechanics Altered
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING SCREWS AND A ROD USED IN CERVICAL SPINE TUMOR RESECTION AND INTERNAL FIXATION THERAPY FOR CERVICAL SPINE TUMOR. LEVELS IMPLANTED: C4-C7 IT WAS REPORTED THAT THE TWO SCREWS COULD NOT BE LOCKED AFTER THE SET SCREWS WERE INSTALLED. AFTER THE CROSSLINK ROD WAS KINKED ONCE, IT COULD NOT BE RESTORED, SO THE OPERATION WAS COMPLETED WITH A REPLACEMENT OF THE SAME MODEL OF THE MEDTRONIC PRODUCT. PATIENT SYMPTOMS ARE UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ROD COULDN'T BE FOLDED BACK INTO THE PATIENT AFTER BEING BENT INTRA-OPERATIVE. NO PATIENT SYMPTOMS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21035398 ↗MalfunctionDec 28, 2024Mechanics Altered; Mechanics Altered
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING SCREWS AND A ROD USED IN CERVICAL SPINE TUMOR RESECTION AND INTERNAL FIXATION THERAPY FOR CERVICAL SPINE TUMOR. LEVELS IMPLANTED: C4-C7 IT WAS REPORTED THAT THE TWO SCREWS COULD NOT BE LOCKED AFTER THE SET SCREWS WERE INSTALLED. AFTER THE CROSSLINK ROD WAS KINKED ONCE, IT COULD NOT BE RESTORED, SO THE OPERATION WAS COMPLETED WITH A REPLACEMENT OF THE SAME MODEL OF THE MEDTRONIC PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ROD COULDN'T BE FOLDED BACK INTO THE PATIENT AFTER BEING BENT INTRA-OP ERATIVE. NO PATIENT SYMPTOMS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21031435 ↗MalfunctionOct 18, 2024Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS CERVICAL MYELOPATHIE. IT WAS REPORTED THAT THE DEFECTIVE CROSSLINKS HAS BEEN CONNECTED, THE SETSCREW WAS BROKEN. LEVELS IMPLANTED WERE C3-T1. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT A NEW CROSSLINK AND SETSCREW WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20479046 ↗InjuryOct 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD TREATMENT OF C ERVICAL SPINE FRACTURE. IT WAS REPORTED THAT THE SET SCREW PLUG HAS COME OUT OF THE SCREW HEAD POST OP. THE IMPLANT LEVEL WAS OCCIPUT PLATE. THERE WAS NO PATIENT SYMPTOM REPORTED. EXPLANT IS PLANNED FOR THE SET SCREW ON (B)(6) 2024. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20357467 ↗InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED SCREW HAVING O-C4 FIXATION THERAPY FOR DECUBITUS INFECTION. IT WAS REPORTED THAT THE SET SCREW OF THE RIGHT OCCIPITAL PLATE AND THE SET SCREW OF THE C4 SCREW DISLODGED. THE ROD WAS SEPARATED FROM THE HEAD OF THE OCCIPITAL BONE PLATE, CAUSING BEDSORES IN THE OCCIPITAL REGION. IN ADDITION, THERE WAS AN INFECTION. THIS EVENT WAS REPEAT SURGERY BECAUSE THERE WAS DEBRIDEMENT AND REMOVAL DUE TO DECUBITUS INFECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE REVISION SURGERY OCCURRED DUE TO INFECTION WAS RELATED TO THE PRODUCTS REPORTED AND THERE WAS NO MALFUNCTION ASSOCIATED WITH THE ROD.
Patient problems: Pressure Sore/Ulcer; Unspecified Infection
MAUDE report 19742689 ↗
Other Medtronic Sofamor Danek, Inc. products
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- METRx System5 models · 672 reports
- INFUSE Bone Graft6 models · 576 reports · 1 recall
- CD HORIZON SOLERA VOYAGER Spinal System60 models · 411 reports
- POWEREASE Instruments8 models · 331 reports · 1 recall
- Catalyft PL Expandable Interbody System16 models · 279 reports · 1 recall
- INFINITY Occipitocervical Upper Thoracic System35 models · 63 reports · 5 recalls
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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