VENTURE™ Anterior Cervical Plate System 9790215Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00721902989322), received between Dec 11, 2019 and Mar 9, 2021 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2021Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF CERVICAL 5/6, 6/7 DISC HERNIATION WITH INCOMPLETE SPINAL CORD NERVE DAMAGE INVOLVED IN ANTERIOR CERVICAL 5/6, 6/7 DISCECTOMY, C6 SLOTTING, DECOMPRESSION OF THE SPINAL CANAL AND INTERVERTEBRAL FORAMINA, INTERVERTEBRAL BONE GRAFT FUSION AND INTERNAL FIXATION PROCEDURE. LEVELS IMPLANTED- C5/6. IT WAS REPORTED THAT DURING PROCEDURE, SCREW SLIPPED. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO ADDITIONAL SURGERY/TREATMENT PERFORMED AS A RESULT OF THIS EVENT. PRODUCT WAS REPLACED. PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11445014 ↗
• MalfunctionNov 9, 2020Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR CERVICAL VERTEBRA DEGENERATION. IT WAS REPORTED THAT THE SELF-TAPPING SCREW SLIPPED DURING THE VENTURE SURGERY AND EXPLANTED. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10807738 ↗
• MalfunctionNov 9, 2020Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR CERVICAL VERTEBRA DEGENERATION. IT WAS REPORTED THAT THE SELF-TAPPING SCREW SLIPPED DURING THE VENTURE SURGERY AND EXPLANTED. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10807736 ↗
• MalfunctionNov 9, 2020Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR CERVICAL VERTEBRA DEGENERATION. IT WAS REPORTED THAT THE SELF-TAPPING SCREW SLIPPED DURING THE VENTURE SURGERY AND EXPLANTED. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 2020-OCT-21: THE LOT NUMBER OF PRODUCT 9790313 IS H5478611. ADDITIONAL INFORMATION WAS RECEIVED ON 2020-OCT-28: THE LOT NUMBERS OF 9790215 IS H5484956 AND 9790313 IS H5478611.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10807406 ↗
• MalfunctionNov 9, 2020Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR CER VICAL VERTEBRA DEGENERATION. IT WAS REPORTED THAT THE SELF-TAPPING SCREW SLIPPED DURING THE VENTURE SURGERY AND EXPLANTED. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 2020-OCT-21: THE LOT NUMBER OF PRODUCT 9790313 IS H5478611. ADDITIONAL INFORMATION WAS RECEIVED ON 2020-OCT-28: THE LOT NUMBERS OF 9790215 IS H5484956, AND 9790313 IS H5478611.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10807358 ↗
• InjurySep 15, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  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 10533371 ↗
• MalfunctionDec 11, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH C6-C7 FRACTURE AND DISLOCATION WITH INCOMPLETE QUADRIPLEGIA AND C6-T1 VERTEBRAL FRACTURE PINCHED FIXATION. SHE UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C6-C7, DECOMPRESSION OF SPINAL CANAL, INTERVERTEBRAL PORE AND SPINAL NERVE RELEASE AND BONE GRAFT FUSION WITH INTERNAL FIXATION. INTRA-OP, THE SCREW BROKE. THE BROKEN SCREW WAS THEN COMPLETELY EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9451460 ↗