VERTEX® Reconstruction System 6950315Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00885074451237), received between Aug 1, 2017 and Sep 7, 2026 — classified as 6 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (16 reports).

1 other recall cover devices cleared under the same FDA submission (K042498, K052180); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• 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 21524255 ↗
• 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 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A REGULATORY BODY VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WHO HAD POSTERIOR CERVICAL SURGERY FOR CERVICAL SPONDYLOTIC MYELOPATHY. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO CERVICAL SPONDYLOTIC MYELOPATHY. ON (B)(6) 2024, HE UNDERWENT POSTERIOR CERVICAL INCISION, DECOMPRESSION, BONE GRAFTING, FUSION AND INTERNAL FIXATION UNDER GENERAL ANESTHESIA. SET SCREW AND FIXATION ROD WERE USED DURING THE OPERATION. DURING THE STAY IN THE HOSPITAL, THE WOUND WAS NORMAL AND THE PATIENT WAS DISCHARGED WITHOUT REMOVING THE STITCHES. PATIENT HAD LOOSENING OF INTERNAL FIXATION. ON (B)(6) 2024, THE PATIENT WAS HOSPITALIZED AGAIN DUE TO POSTOPERATIVE INFECTION OF THE CERVICAL SPINE. DEBRIDEMENT WAS PERFORMED ALONG WITH PERFUSION AND DRAINAGE AND THE PATIENT WAS DISCHARGED AFTER HEALING. PATIENT HAD A HISTORY OF DIABETES AND POOR BLOOD SUGAR CONTROL AND DID NOT MONITOR HIS BLOOD SUGAR AFTER DISCHARGE. PATIENT DID NOT FOLLOW THE DOCTOR'S INSTRUCTIONS TO CHANGE THE MEDICINE REGULARLY AT THE MEDICAL INSTITUTION, BUT CHANGED THE MEDICINE AT HOME ON HIS OWN, AND DID NOT HAVE A STRONG SENSE OF STERILITY. THERE WERE NO FURTHER COMPLICATIO

  Patient problems: Post Operative Wound Infection

  MAUDE report 19719124 ↗
• MalfunctionJan 10, 2023Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPINAL DEVICE USED IN POSTERIOR CERVICAL DECOMPRESSION PLUS OCCIPITOCERVICAL FIXATION. IT WAS REPORTED THAT THE NUT SLIPPED AND WAS DIFFICULT TO SCREW IN. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS CERVICAL SPINAL STENOSIS. THERE WERE NO PATIENT SYMPTOMS IN THIS EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16128764 ↗
• MalfunctionNov 1, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING POSTERIOR CERVICAL PATHWAY STAPLING ROD SYSTEM TECHNOLOGY THERAPY FOR FRACTURE DISLOCATION. IT WAS REPORTED THAT THE SCREW SLIPPED. THERE WERE NO PATIENT SYMPTOMS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPO RTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15707203 ↗
• MalfunctionAug 4, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR CERVI CAL FIXATION FOR 7 CERVICAL SPONDYLOLISTHESIS, DEGENERATIVE CHANGES OF CERVICAL VERTEBRA 4-5 AND 5-6. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO NECK TRAUMA. THE DOCTOR PERFORMED CERVICAL 5-THORACIC 1 SURGERY AFTER ADMISSION. THE CERVICAL VERTEBRA 7 AND THORACIC VERTEBRA 1 WERE IMPLANTED WITH PEDICLE SCREWS, AND THEN THE ROD WAS PUSHED. DURING PUSHING THE ROD AND SCREW, FOUR 6950315 SCREWS WERE SLIPPED. PRODUCT EXPLANTED AND WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITION INFORMATION RECEIVED FROM MANUFACTURING REPRESENTATIVE AND CONFIRMED THAT THERE WERE NO PATIENT COMPLICATION HAPPENED DUE TO SCREW SLIPPAGE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15162235 ↗
• MalfunctionJul 27, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM DISTRIBUTOR, HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A SETSCREW USED FOR SPINAL SURGERY. PRE-OP DIAGNOSIS WAS LUMBAR DISC HERNIATION. PROCEDURE PERFORMED IN THE EVENT WAS TLIF. IT WAS REPORTED THAT INTRA-OPERATIVELY, SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH PATIENT. THERE WAS NO DELAY IN THE OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114030 ↗
• MalfunctionJul 27, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR CERVI CAL FIXATION SURGERY FOR AN INDICATION OF CERVICAL DISC HERNIATION. IT WAS REPORTED THAT WHEN THE SCREW PLUG WAS SCREWED IT, IT SLIPPED. 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 15109519 ↗
• MalfunctionJul 26, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE SCREW SLIPPED. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15100696 ↗
• MalfunctionJul 21, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT H AVING POSTERIOR CERVICAL FIXATION SURGERY DUE TO CERVICAL DISC HERNIATION. IT WAS REPORTED THAT SCREW SLIPPED. THERE WAS NO SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15071755 ↗
• MalfunctionJul 21, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT H AVING POSTERIOR CERVICAL FIXATION SURGERY DUE TO CERVICAL DISC HERNIATION. IT WAS REPORTED THAT SCREW SLIPPED. THERE WAS NO SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15071749 ↗
• MalfunctionJul 20, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR AND HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A POSTERIOR CERVICAL FIXATION FOR CERVICAL DISC HERNIATION. IT WAS REPORTED THAT THE SCREWS WERE EXPLANTED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRODUCTS SLIPPED DURING SURGERY. THE PRODUCTS CAME IN CONTACT WITH THE IMPLANTED SCREW IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15062758 ↗
• MalfunctionJul 20, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR AND HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A POSTERIOR CERVICAL FIXATION FOR CERVICAL DISC HERNIATION. IT WAS REPORTED THAT THE SCREWS WERE EXPLANTED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRODUCTS SLIPPED DURING SURGERY. THE PRODUCTS CAME IN CONTACT WITH THE IMPLANTED SCREW IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15062743 ↗
• MalfunctionJul 20, 2022Device Slipped; Device Slipped

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER, DISTRIBUTOR VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED PRODUCT. THE PRE-OP DIAGNOSIS WAS MENTIONED AS HERNIATED DISC. IT WAS REPORTED THAT, THE SCREW WAS SLIPPED. INTRA-OPERATIVELY THE SCREW PLUG SLIPPED. THE REPORTED PRODUCT CAME IN CONTACT WITH PATIENT BODY. THERE WAS NO TIME DELAY IN PROCEDURE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AND NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. THE PROCEDURE OR TECHNIQUE PERFORMED WAS POSTERIOR CERVICAL FIXATION SURGERY. NO FURTHER COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15062720 ↗
• MalfunctionJul 19, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A DISTRIBUTOR/ MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW IN A POSTERIOR CERVICAL SPINE FIXATION SURGERY FOR A CERVICAL DISC HERNIATION. IT WAS REPORTED THAT THE SCREW SLIPPED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE DATE OF IMPLANT AND EXPLANT WAS (B)(6) 2020. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15050449 ↗
• MalfunctionJul 18, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A DISTRIBUTOR/ MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW IN A POSTERIOR CERVICAL SCREW ROD SYSTEM FOR INTERNAL FIXATION FOR A CERVICAL NERVE COMPRESSION. IT WAS REPORTED THAT THE SCREW SLIPPED INTRAOPERATIVELY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE DATE OF IMPLANT AND EXPLANT WAS (B)(6) 2020. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15037704 ↗
• MalfunctionJul 6, 2022Device Slipped; Device Slipped

  THE INFORMATION WAS RECEIVED FROM DISTRIBUTOR VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH CERVICAL DISC HERNIATION FOR POSTERIOR CERVICAL FIXATION SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW WAS SLIPPED. THE PART CAME IN CONTACT WITH PATIENT. THERE WAS NO FURTHER INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14927742 ↗
• MalfunctionMar 25, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A LUMBAR SPINE FUSION SURGERY IN A PATIENT DIAGNOSED WITH LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE SCREW SLIPPED DURING IMPLANTATION. NO PATIENT INJURY / COMPLICATION. PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13899267 ↗
• InjuryNov 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- CHIN ON CHEST DEFORMITY INVOLVED IN THE POSTERIOR CERVICAL FUSION. ADDITION OF OCCIPITAL PLATE AND RODS TO EXISTING IMPLANT CONSTRUCT. LEVELS IM PLANTED- OCCIPUT TO T2. IT WAS REPORTED THAT POST-OPERATIVELY, THE OCCIPITAL ROD MECHANISM "FELL APART" SHORTLY AFTER SURGERY ON (B)(6) 2017. THEY DECIDED TO TREAT THE PATIENT WITH A HALO DEVICE RATHER THAN ANOTHER SURGERY TO REPLACE FAILED IMPLANTS. THE PATIENT EVENTUALLY HAD DIFFICULTY LOOKING STRAIGHT AHEAD, SO THEY SCHEDULED A REVISION OF THE OCCIPITAL RODS AND CORRECTION OF THE SAGITTAL DEFORMITY. THE PATIENT INCURRED A VASCULAR INJURY DURING THE REVISION ON 10/19/2021 AND THEY WERE UNABLE TO COMPLETE THE SURGERY. ON 2021-OCT-22, RECEIVED ADDITIONAL INFORMATION THAT PATIENT HAD SUFFERED A MAJOR STROKE. IT HAS ALSO BEEN REPORTED TO THAT PATIENT HAD PASSED AROUND 6PM ON (B)(6) 2021. ON 2021-OCT-27, RECEIVED ADDITIONAL INFORMATION THAT AS PER A/P X-RAY IMAGE ON (B)(6) 2017, THE HINGE OF THE ROD ON THE RIGHT WAS DISCONNECTED. ON THE LATERAL X-RAY IMAGE OF (B)(6) 2017 THE PROXIMAL EXTENSION OF THE ROD THAT CONNECTS TO THE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12817966 ↗
• MalfunctionJul 16, 2020Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH POSTERIOR CERVICAL SURGERY. IT WAS REPORTED THAT THE SCREW PLUG SLIPPED. THERE WAS NO FRAGMENT LEFT OR CONTACT WITH THE PATIENT. THERE WERE NO SYMPTOMS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10281242 ↗
• InjuryApr 24, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CERVICAL SPINE INSTABILITY POST INJURY AND ANTERIOR STABILIZATION WITH FIXATION. HE UNDERWENT THE FOLLOWING CERVICAL SPINAL STABILIZATION PROCEDURES: POSTERIOR CERVICAL INSTRUMENTATION, FIXATION AND FUSION AT C3-C6. ON AN UNKNOWN DATE, POST-OP, DURING STANDARD POST-SURGICAL FOLLOW-UP EXAM, THE PATIENT NOTED EXPERIENCING/ FEELING A POP. STANDARD FOLLOW-UP X-RAYS SHOWED DISENGAGEMENT OF SET SCREW AT THE TERMINAL, CEPHALAD END OF CONSTRUCT ON PATIENT'S RIGHT SIDE. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH THE DISENGAGED/ DISLODGED SET SCREW WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9996399 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042498, K052180. One submission often covers many models, so check the product and lot details in each record.

• Z-2877-2011 · Jun 28, 2011 · Terminated
  VERTEX (R), REF 69004440, cortical screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization and stabilization of