VENTURE™ Anterior Cervical Plate System 9790315Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00721902989704), received between Apr 21, 2020 and Sep 15, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2020Nonstandard Device; Nonstandard Device

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA FIELD REPRESENTATIVE REGARDING A PATIENT WHO UNDERGONE SPINAL THERAPY WITH A PRE-OPERATIVE DIAGNOSIS OF CERVICAL FRACTURE. IT WAS REPORTED THAT AFTER THE FIRST SURGERY, THE PATIENT DEVELOPED NEUROLOGIC SYMPTOMS AND UNDERWENT A REVISION SURGERY THE NEXT DAY TO REMOVE THE FOUR SCREWS OF THE FIRST SURGERY. THE PRODUCTS HAVE BEEN IMPLANTED IN THE PATIENT, AND THE LARGER DIAMETER SCREWS HAVE BEEN USED DURING THE SECONDARY REVISION SURGERY. THE SIZE OF THE SCREW IMPLANTS THAT WERE IMPLANTED DURING THE REVISION SURGERY WAS WITH DIAMETER OF 4.5. THE SECOND REVISION SURGERY WAS PERFORMED WITHIN 24 HOURS AFTER THE FIRST SURGERY, AND THESE SCREWS CAN NO LONGER BE USED. THERE WAS NO DEVICE BREAKAGE AND PRODUCT UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Movement Disorder; Neurological Deficit/Dysfunction

  MAUDE report 10533400 ↗
• InjurySep 15, 2020Nonstandard Device; Nonstandard Device

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA FIELD REPRESENTATIVE REGARDING A PATIENT WHO UNDERGONE SPINAL THERAPY WITH A PRE-OPERATIVE DIAGNOSIS OF CERVICAL FRACTURE. IT WAS REPORTED THAT AFTER THE FIRST SURGERY, THE PATIENT DEVELOPED NEUROLOGIC SYMPTOMS AND UNDERWENT A REVISION SURGERY THE NEXT DAY TO REMOVE THE FOUR SCREWS OF THE FIRST SURGERY. THE PRODUCTS HAVE BEEN IMPLANTED IN THE PATIENT, AND THE LARGER DIAMETER SCREWS HAVE BEEN USED DURING THE SECONDARY REVISION SURGERY. THE SIZE OF THE SCREW IMPLANTS THAT WERE IMPLANTED DURING THE REVISION SURGERY WAS WITH DIAMETER OF 4.5. THE SECOND REVISION SURGERY WAS PERFORMED WITHIN 24 HOURS AFTER THE FIRST SURGERY, AND THESE SCREWS CAN NO LONGER BE USED. THERE WAS NO DEVICE BREAKAGE AND PRODUCT UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Movement Disorder; Neurological Deficit/Dysfunction

  MAUDE report 10533389 ↗
• InjuryApr 21, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PRE OP DIAGNOSIS: SPINAL CORD INJURY PROCEDURE PERFORMED: ANTERIOR 4 CERVICAL SUBTOTAL VERTEBRAL BODY SUBTOTAL RESECTION, CERVICAL 3-4, 4-5 DISCECTOMY, SPINAL CANAL AND SPINAL NERVE DECOMPRESSION, BONE GRAFT FUSION AND INTERNAL FIXATION POST OP, THE SCREW LOOSEN AND STEEL PLATE MIGRATED. THE PATIENT DEVELOPED NEW NEUROLOGICAL SYMPTOMS, AND THE PATIENT'S LOWER LIMB DE CREASED SENSATION. AS A RESULT OF THIS REVISION SURGERY WAS PERFORMED. IN REVISION SURGERY THEY REMOVED THE ORIGINAL STEEL PLATE, RE-EXPANDED THE DECOMPRESSION RANGE, AND REPLACED WITH A LONGER STEEL PLATE.

  Patient problems: Hyporesponsive to stimuli; Neurological Deficit/Dysfunction

  MAUDE report 9980444 ↗
• InjuryApr 21, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PRE OP DIAGNOSIS: SPINAL CORD INJURY PROCEDURE PERFORMED: ANTERIOR 4 CERVICAL SUBTOTAL VERTEBRAL BODY SUBTOTAL RESECTION, CERVICAL 3-4, 4-5 DISCECTOMY, SPINAL CANAL AND SPINAL NERVE DECOMPRESSION, BONE GRAFT FUSION AND INTERNAL FIXATION POST OP, THE SCREW LOOSEN AND STEEL PLATE MIGRATED. THE PATIENT DEVELOPED NEW NEUROLOGICAL SYMPTOMS, AND THE PATIENT'S LOWER LIMB DE CREASED SENSATION. AS A RESULT OF THIS REVISION SURGERY WAS PERFORMED. IN REVISION SURGERY THEY REMOVED THE ORIGINAL STEEL PLATE, RE-EXPANDED THE DECOMPRESSION RANGE, AND REPLACED WITH A LONGER STEEL PLATE.

  Patient problems: Hyporesponsive to stimuli; Neurological Deficit/Dysfunction

  MAUDE report 9980441 ↗