VENTURE Anterior Cervical Plate SystemRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 9 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 9 models of VENTURE Anterior Cervical Plate System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Oct 5, 2017 and Mar 9, 2021 — classified as 9 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Device Slipped” (6 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. 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
Most reported VENTURE Anterior Cervical Plate System problems
Device problems
- Device Slipped6
- Migration or Expulsion of Device4
- Loosening of Implant Not Related to Bone-Ingrowth2
- Migration2
- Nonstandard Device2
- Break1
- Fail-Safe Problem1
- Failure to Align1
Patient problems
- No Known Impact Or Consequence To Patient11
- Neurological Deficit/Dysfunction6
- No Clinical Signs, Symptoms or Conditions6
- Hyporesponsive to stimuli3
- Movement Disorder3
- Skin Tears1
VENTURE Anterior Cervical Plate System models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VENTURE™ Anterior Cervical Plate System 9790215APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY7 reports
- VENTURE™ Anterior Cervical Plate System 9790315APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY4 reports
- VENTURE™ Anterior Cervical Plate System 9790035APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- VENTURE™ Anterior Cervical Plate System 9790052APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- VENTURE™ Anterior Cervical Plate System 9790065APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- VENTURE™ Anterior Cervical Plate System 9790213APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- VENTURE™ Anterior Cervical Plate System 9790317APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- VENTURE™ Anterior Cervical Plate System 9791221APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- VENTURE™ Anterior Cervical Plate System 9791325APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
Recent VENTURE Anterior Cervical Plate System adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJan 15, 2021Device Slipped
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A FIELD CONTACT REGARDING A PATIENT WITH A PRE-OPERATIVE DIAGNOSIS OF C4/C5 RADICULOPATHY CERVICAL SPONDYLOSIS, UNDERGOING A ANTERIOR CERVICAL 4/5, CERVICAL 5/6 DISCECTOMY, BILATERAL SPINAL NERVE LYSIS, INTERVERTEBRAL BONE GRAFT FUSION AND INTERNAL FIXATION PROCEDURE. IT WAS REPORTED THAT THE SET SCREW SLIPPED AND COULDN'T BE FIXED. THERE WERE NO PATIENT SYMPTOMS/COMPLICATIONS. THE PRODUCT WILL BE RETURNED AND WAS REPLACED. DEVICE STATUS REASON : EXPLANTED-COMPLETE THERE WAS NO DELAY IN THE OVERALL PROCEDURE TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11175989 ↗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, 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 ↗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 ↗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 ↗InjuryApr 21, 2020Migration; Migration
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, STEEL PLATE MIGRATED. THE PATIENT DEVELOPED NEW NEUROLOGICAL SYMPTOMS, AND THE PATIENT'S LOWER LIMB DECREASED 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 9980295 ↗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 ↗MalfunctionMay 20, 2019Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGERY AT C5/6/7 DUE TO SOME UNKNOWN REASON. POST-OP, THE SCREW AT THE BOTTOM OF C7 BACKED OUT THROUGH THE LOCKING MECHANISM ON THE PLATE. NO ADDITIONAL SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8623122 ↗MalfunctionApr 19, 2019Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) FROM C5-C7 WITH PLATE AND SCREWS. POST-OP, LOCKING MECHANISM ON THE IMPLANTED PLATE FAILED TO PREVENT A SCREW FROM BACKING THROUGH IT SLIGHTLY. NO ADDITIONAL SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT YET. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8530469 ↗
Other Medtronic Sofamor Danek, Inc. products
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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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