CAVUX Cervical Cage-T PD-31-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00852776006010), received between Nov 9, 2016 and Jun 8, 2017 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2017Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  THE PATIENT HAD A PREVIOUS C5-C7 FORAMINOTOMY SURGERY IN 2007 DUE TO HEAVINESS IN THE RIGHT ARM WHEN LIFTING, WEAK TRICEPS, TINGLING IN THE FINGERS, AND PAIN DOWN THE ARM WHEN EXTENDING THE NECK (E.G. LOOKING UP) BUT NOT BENDING THE NECK IN FLEXION (E.G. LOOKING DOWN). IN MID-2015, THE PATIENT STARTED TO EXPERIENCE THE RETURN OF THE PRE-2007 SYMPTOMS. CT SCAN SHOWED BONE SPURS AT C4-C5. ON (B)(6) 2015, THE PATIENT RECEIVED A CERVICAL FUSION PROCEDURE USING PROVIDENCE CAGE-T IMPLANT. TWO DAYS AFTER THE SURGERY, THE PATIENT REPORTED DIFFICULTY FLEXING HIS RIGHT ELBOW (COULDN'T LIFT MORE THAN 2 LBS. AND "THE RIGHT DELTOID AND TRICEPS WERE OUT"). THE SYMPTOMS DID NOT GO AWAY AFTER TAKING MEDROL PRESCRIBED BY THE SURGEON WHO DID THE IMPLANT. THE PATIENT, AFTER REVIEWING THE INTRA-OP X-RAY IMAGES, REPORTED SEEING THE IMPLANT WAS SLIGHTLY PROUD INTO THE RIGHT FORAMEN POSSIBLY INTERFERING WITH C5 NERVE. THE UNRESOLVED SYMPTOMS, RIGHT-HAND WEAKNESS AND NUMBNESS BILATERALLY IN INDEX AND THUMB PHALANGES, CONTINUES TO-DATE WITHOUT ANY INDICATION OF IMPROVEMENT. THERE WAS NO DEVICE DEFECT OR RE-INTERVENTION INDICATED IN THIS CASE. IT IS NOTED THAT THE PATIENT IS A SPINAL SURGEON HIMSELF. (B)(4)

  Patient problems: Disability; Muscle Weakness/Atrophy; Nerve Proximity Nos (Not Otherwise Specified); Numbness; Weakness

  MAUDE report 6622774 ↗
• InjuryNov 9, 2016Malposition of Device; Patient-Device Incompatibility; Positioning Problem; Malposition of Device; Patient-Device Incompatibility; Positioning Problem

  A PATIENT, WHO HAD A C5-C7 ACDF WITH C6 CORPECTOMY TWO YEARS AGO (IN 2012), EXPERIENCED RADICULAR SYMPTOMS (NECK AND ARM PAIN) IN 2013 AND RECEIVED A C5-C7 POSTERIOR CERVICAL FUSION ON (B)(6) 2014. AFTER THE CERVICAL FUSION, THE PATIENT'S RADICULAR SYMPTOM (NECK AND ARM PAIN) WAS NOT RESOLVED. THE SURGEON DISCOVERED THROUGH POST-OP CT SCAN EXAMINATION THAT THE RIGHT C5 INFERIOR ARTICULAR PROCESS AND RIGHT C6 SUPERIOR PROCESS WERE FRACTURED WHICH MAY HAVE LED TO A CAGE MIGRATION THAT RESULTED IN THE C6 NERVE IMPINGEMENT. THE PATIENT RECEIVED A REVISION TO REMOVE THE CAGE LOCATED AT C5-C6. THE PATIENT DID NOT REPORT ANY NEW OR WORSENING SYMPTOMS AFTER REVISION. THERE WAS NO DEVICE MALFUNCTION REPORTED IN THIS CASE.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 6090174 ↗
• MalfunctionNov 9, 2016Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  A PATIENT WHO HAD PRIOR ACDF RECEIVED A POSTERIOR CERVICAL FUSION AND EXPERIENCED PAIN AFTER SURGERY. THE SURGEON DISCOVERED THROUGH POST-OP CT SCAN EXAMINATION THAT ONE OF THE CAGES WAS PLACED TOO MEDIALLY RESULTING IN NERVE ROOT IMPINGEMENT. THE PATIENT RECEIVED A REVISION TO REMOVE THAT CAGE. THE PATIENT DID NOT REPORT ANY NEW OR WORSENING SYMPTOMS AFTER REVISION. THERE WAS NO DEVICE MALFUNCTION REPORTED IN THIS CASE.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 6090154 ↗