CAVUX™ Cervical Cage SB PD-31-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00852776006423), received between Jan 27, 2020 and Aug 28, 2020 — classified as 7 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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, 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.

• InjuryAug 28, 2020Malposition of Device; Malposition of Device

  ON (B)(6) 2020 A PATIENT RECEIVED A SINGLE LEVEL POSTERIOR CERVICAL FUSION WITH CERVICAL CAGES PLACED POSTERIORLY AT C6-C7. THE PATIENT HAD A PREVIOUS 3-LEVEL ACDF AND A PREVIOUS C7-T1 POSTERIOR CERVICAL FUSION. THE PATIENT RETURNED ONE DAY LATER COMPLAINING OF RIGHT ARM PAIN, INITIATING IMAGING. IN A POST-OPERATIVE CT, THE SURGEON SUSPECTED THE CERVICAL CAGES WERE MALPOSITIONED. THE CERVICAL CAGE ON THE RIGHT SIDE WAS REMOVED AND REPLACED WITH ANOTHER PROVIDENCE MEDICAL TECHNOLOGY CERVICAL CAGE. ALSO, THE CERVICAL CAGE ON THE LEFT SIDE WAS ALSO MALPOSITIONED AND REPOSITIONED. PATIENT IS RECOVERING WELL WITH NO ARM PAIN. NO DEVICE DEFECT OR MALFUNCTION WAS REPORTED.

  Patient problems: Neck Pain

  MAUDE report 10469090 ↗
• InjuryAug 28, 2020Malposition of Device; Malposition of Device

  ON (B)(6) 2020, A PATIENT UNDERWENT A 2-LEVEL CIRCUMFERENTIAL CERVICAL FUSION WITH CERVICAL CAGES PLACED POSTERIORLY BILATERALLY. THE SAME DAY, THE PATIENT COMPLAINED OF RIGHT-SIDED DELTOID WEAKNESS, INITIATING A CT SCAN. THE CAGE AT C4-C5 ON THE RIGHT WAS NOTED TO BE POTENTIALLY MALPOSITIONED, WHICH COULD HAVE CONTRIBUTED TO THE DELTOID WEAKNESS. THE SAME DAY (EVENING), THE PATIENT UNDERWENT A REVISION PROCEDURE TO THE OR TO REMOVE THE CERVICAL CAGE AT C4-C5 ON THE RIGHT DURING WHICH TIME THE SURGEON PERFORMED A FORAMINOTOMY AND PLACED LATERAL MASS SCREWS. NO DEVICE DEFECT OR MALFUNCTION WAS REPORTED. THE PATIENT IS RECOVERING WITH NO CLINICAL SEQUELAE.

  Patient problems: Muscle Weakness/Atrophy; Neck Pain

  MAUDE report 10469030 ↗
• InjuryAug 10, 2020Malposition of Device; Malposition of Device

  ON (B)(6) 2020, A MALE PATIENT UNDERWENT A CIRCUMFERENTIAL CERVICAL FUSION WITH CERVICAL CAGES PLACED POSTERIORLY, UNILATERALLY, ON THE LEFT AT C4-C5 AND C5-C6. THREE AND A HALF MONTHS LATER ON (B)(6) 2020, THE PATIENT RETURNED COMPLAINING OF PAIN. IMAGING CONFIRMED CAGES WERE PROUD POSTERIORLY WHICH POTENTIALLY CONTRIBUTED TO THE POST-OPERATIVE PAIN. BOTH CERVICAL CAGES PLACED POSTERIORLY WERE REMOVED ON (B)(6) 2020. NO DEVICE DEFECT OR MALFUNCTION WAS REPORTED. PATIENT IS RECOVERING WELL WITH IMPROVED SYMPTOMS.

  Patient problems: Neck Pain

  MAUDE report 10388802 ↗
• InjuryMay 12, 2020Malposition of Device; Malposition of Device

  A (B)(6)-YEAR-OLD MALE UNDERWENT POSTERIOR CERVICAL FUSION SURGERY ON (B)(6) 2020 WITH CERVICAL CAGES PLACED BILATERALLY POSTERIORLY AT C4-C5, C5-C6, C6-C7. PATIENT IS A SMOKER AND HAS HISTORY OF PREVIOUS CERVICAL SPINAL SURGERY; PROCEDURE WAS TO ADDRESS PSEUDARTHROSIS FROM PREVIOUS SURGERY. ALL SIX CERVICAL CAGES WERE IMPLANTED SUCCESSFULLY BUT A NOTE WAS MADE ABOUT DIFFICULTY TO ACCESS FACET JOINT DUE TO PATIENT ANATOMY AND PREVIOUS SURGERY. APPROXIMATELY 3 WEEKS LATER, PATIENT COMPLAINED OF RIGHT SIDE PAIN PROMPTING IMAGING TO BE TAKEN. IMAGING SUGGESTED CERVICAL CAGES PLACED ON THE RIGHT SIDE MAY BE MAL-POSITIONED, POTENTIALLY CAUSING PATIENT PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO REMOVE ALL THREE CERVICAL CAGES PLACED ON THE RIGHT SIDE (C4-C7) AND REPLACE WITH LATERAL MASS INSTRUMENTATION. NO DEVICE DEFECT OR MALFUNCTION WAS REPORTED. PATIENT IS RECOVERING AS EXPECTED.

  Patient problems: Neck Pain

  MAUDE report 10048252 ↗
• InjuryApr 6, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  FEMALE PATIENT WITH HISTORY OF PREVIOUS CERVICAL SPINAL FUSION SURGERY UNDERWENT 1 LEVEL POSTERIOR CERVICAL FUSION WITH CERVICAL CAGES PLACED POSTERIORLY AT C7-T1 AND PARTIAL FORAMINOTOMY (ON RIGHT SIDE) ON (B)(6) 2019. PATIENT CONTINUED TO COMPLAIN OF PAIN AND PSEUDARTHROSIS WAS NOTED AT C7-T1 LIKELY DUE TO THE DEVELOPMENT OF EXCESSIVE SCAR TISSUE (ACCORDING TO THE SURGEON). ON (B)(6) 2020, CERVICAL CAGES PLACED POSTERIORLY BILATERALLY AT C7-T1 WERE REMOVED AND REPLACED. BOTH SURGERIES WENT AS EXPECTED WITH NO REPORTED DEVICE DEFECT OR MALFUNCTIONS. PATIENT IS RECOVERING WELL. CAVUX CERVICAL CAGE-B IS NOT INDICATED FOR USE AT C7-T1.

  Patient problems: Neck Pain

  MAUDE report 9931631 ↗
• InjuryMar 31, 2020Malposition of Device; Malposition of Device

  PATIENT UNDERWENT POSTERIOR FUSION ON (B)(6) 2018 WITH CERVICAL CAGES PLACED POSTERIORLY AT C6-C7 AND C7-T1. HOWEVER, C5-C6 AND C6-C7 WERE INTENDED TREATMENT LEVELS. POST PROCEDURE, PATIENT COMPLAINED OF RIGHT ARM PAIN INITIATING A CT SCAN. THE CT SCAN CONFIRMED TWO OF FOUR CERVICAL CAGES PLACED POSTERIORLY, AT C6-C7 AND C7-T1 ON THE RIGHT, WERE MALPOSITIONED AND COULD BE CONTRIBUTING TO NEURITIS. ON (B)(6) 2018, THE SURGEON REMOVED ONE CAGE AT C7-T1 ON THE RIGHT. THE CERVICAL CAGE AT C6-C7 WAS FOUND TO BE PLACED DEEPER THAN AN IDEAL POSITION AND COULD CONTRIBUTE TO RIGHT ARM PAIN BUT THE CERVICAL CAGE AT THIS LEVEL WAS NOT REMOVED. PATIENT RECEIVED AN ACDF AT C6-C7 FROM ANOTHER SURGEON IN 2019. THE CERVICAL CAGE AT C6-C7 WAS NOT TOUCHED AT THIS TIME. NO DEVICE DEFECT OR MALFUNCTION OR PERMANENT IMPAIRMENT WAS REPORTED BY EITHER SURGEON. THE SURGEONS WERE NOT ABLE TO BE REACHED FOR AN UPDATE ON THE PATIENT BUT NO OTHER CLINICAL SEQUELAE HAVE BEEN DOCUMENTED.

  Patient problems: Neck Pain

  MAUDE report 9908595 ↗
• InjuryJan 27, 2020Malposition of Device; Malposition of Device

  FEMALE PATIENT UNDERWENT SUCCESSFUL CIRCUMFERENTIAL FUSION ON (B)(6) 2020 WITH INTERBODY DEVICES PLACED ANTERIORLY AND CERVICAL CAGES PLACED POSTERIORLY AT C5-C6 AND C6-C7. 3 DAYS POST PROCEDURE, PATIENT COMPLAINED OF SHOULDER AND TRICEP PAIN INITIATING A CT SCAN. THE CT SCAN CONFIRMED ONE OF FOUR CERVICAL CAGES POSTERIORLY, AT C6-C7 ON THE RIGHT, WAS MALPOSITIONED AND COULD BE CONTRIBUTING TO NERVE ROOT IRRITATION AND PAIN. ON (B)(6) 2020, THE SURGEON REMOVED THE CAGE AND PERFORMED A FORAMINOTOMY AT C6-C7 ON THE RIGHT. NO DEVICE DEFECT OR MALFUNCTION OR PERMANENT IMPAIRMENT WAS REPORTED BY THE SURGEON. THE SURGEON HYPOTHESIZED THAT SHALLOW FACETS AND ANTERIOR DISTRACTION COULD HAVE CONTRIBUTED TO CAGE MALPOSITION. THE PATIENT IS HEALING AS EXPECTED WITH NO SUBSEQUENT ISSUES.

  Patient problems: Neck Pain

  MAUDE report 9635213 ↗