CoRoent 6791714Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00887517362414), received between Sep 29, 2016 and Feb 8, 2024 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2024Fracture; Fracture

  A PATIENT REPORTED THAT APPROXIMATELY 13 MONTHS AFTER AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE WAS PERFORMED AT C4/5 AND C5/6, IT WAS FOUND, DURING A CT SCAN, THAT TWO SCREWS FIXATING THE INTERBODY AT C5/6 HAD FRACTURED. REPORTEDLY, THERE WAS NO EXTREME FORCE APPLIED TO THE SCREWS; HOWEVER, THE PATIENT REPORTED THE SCREWS FRACTURED WHILE ENGAGING IN NERVE GLIDE EXERCISES. THERE IS NO INDICATION THAT THE FRACTURED SCREWS WERE REMOVED; HOWEVER, THE PATIENT REPORT ALLEGES THE PATIENT UNDERWENT A SUBSEQUENT POSTERIOR FUSION PROCEDURE AS A RESULT OF THE FRACTURED SCREWS. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 2 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 18673064 ↗
• InjuryMay 16, 2023Fracture; Fracture

  A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE FROM C3 TO C6 WITHOUT ANY ISSUES. APPROXIMATELY NINE MONTHS LATER, THE PATIENT HAD A FOLLOW UP APPOINTMENT WHERE X-RAYS SHOWED NO ISSUES WITH THE CONSTRUCT AND THERE WERE NO CONCERNS WITH THE PATIENT'S FUSION PROGRESS. APPROXIMATELY 32 MONTHS AFTER THE INDEX PROCEDURE, X-RAYS REVEALED SCREWS WERE FRACTURED AT C5/6 AND ALSO REVEALED THE PATIENT DID NOT APPEAR TO HAVE COMPLETELY FUSED, WITH NO FURTHER FUSION PROGRESSION BEYOND WHAT WAS NOTED IN THE NINE-MONTH X-RAYS. IT WAS ALSO REPORTED THE PATIENT HAD BEGUN EXPERIENCING NEW ARM AND NECK PAIN; SPECIFICALLY, ADJACENT LEVEL C6/7 PAIN AND SOME NEW C6 PATTERN PAIN THAT MAY HAVE BEEN RELATED TO THE PATIENT'S LACK OF FUSION/NON-UNION. NO REVISION WAS CONSIDERED AS THE PATIENT HAD MULTIPLE, UNIDENTIFIED MEDICAL MORBIDITIES AND DID NOT WISH TO RETURN FOR FURTHER CERVICAL SURGERY. NO FURTHER TREATMENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 16943322 ↗
• MalfunctionDec 23, 2020Fracture; Fracture

  A PATIENT REPORTED THAT APPROXIMATELY 13 MONTHS AFTER AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE WAS PERFORMED AT C4/5 AND C5/6, IT WAS FOUND, DURING A CT SCAN, THAT TWO SCREWS FIXATING THE INTERBODY AT C5/6 HAD FRACTURED. REPORTEDLY, THERE WAS NO EXTREME FORCE APPLIED TO THE SCREWS; HOWEVER, THE PATIENT REPORTED THE SCREWS FRACTURED WHILE ENGAGING IN NERVE GLIDE EXERCISES. THERE IS NO INDICATION THAT THE FRACTURED SCREWS WERE REMOVED; HOWEVER, THE PATIENT REPORT ALLEGES THE PATIENT UNDERWENT A SUBSEQUENT POSTERIOR FUSION PROCEDURE AS A RESULT OF THE FRACTURED SCREWS. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 1 OF 2.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 11067578 ↗
• MalfunctionJun 14, 2018Fracture; Fracture

  ON (B)(6) 2014, PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE. AS PER REPORTER APPROXIMATELY 24 MONTHS POST-OPERATIVELY, RADIOGRAPHS SHOWED A SCREW FRACTURE AT C5 LEVEL. NO REVISION PROCEDURE WILL BE PERFORMED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 7603852 ↗
• InjuryJun 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE. AS PER REPORTER APPROXIMATELY 5 WEEKS POSTOPERATIVELY RADIOGRAPHS INDICATED ACUTE KYPHOTIC DEFORMITY AND A VERTEBRAL BODY FRACTURE WAS NOTED AT C4 LEVEL. PATIENT UNDERWENT A CERVICAL CT SCAN FOR FURTHER EVALUATION AND WAS PRESCRIBED A CERVICAL COLLAR. SURGEON HAS DISCUSSED THE NEED FOR REVISION PROCEDURE. NO REVISION PROCEDURE HAS BEEN REPORTED.

  Patient problems: Bone Fracture(s); Patient Problem/Medical Problem

  MAUDE report 7603649 ↗
• MalfunctionFeb 16, 2018Fracture; Fracture

  ON (B)(6) 2016 PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE AT C5-C6 LEVELS. DURING THE 6 MONTH VISIT A FLEXION/EXTENSION RADIOGRAPH SHOWED A BROKEN SCREW AT C6. AS PER REPORTER SURGEON NOTED POTENTIAL PSEUDOARTHROSIS AT C6-C7 LEVELS. PATIENT IS CURRENTLY SEEING PAIN MANAGEMENT, NO REVISION PROCEDURE HAS BEEN PLANNED AT THIS TIME.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7277088 ↗
• MalfunctionNov 21, 2017Fracture; Fracture

  ON (B)(6) 2016 A PATIENT UNDERWENT A SELF-FIXATING INTERBODY REPLACEMENT PROCEDURE WITHOUT ANY REPORTED ISSUES. ON (B)(6) 2016 DURING A ROUTINE POST-INDEX PROCEDURE A FOLLOW UP RADIOGRAPHS SHOWED THE INFERIOR C4-5 LEVEL SCREW HAD FRACTURED. THE PATIENT IS ASYMPTOMATIC NO REVISION PROCEDURE IS PLANNED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 7051410 ↗
• MalfunctionNov 21, 2017Fracture; Fracture

  ON (B)(6) 2013 A PATIENT UNDERWENT A SELF-FIXATING INTERBODY REPLACEMENT PROCEDURE WITHOUT REPORTED ISSUES. ON (B)(6) 2015 THE PATIENT SUFFERED A FALL AND EXPERIENCED NECK AND SHOULDER PAIN. RADIOGRAPH AND CT IMAGES SHOWED THE 2 SCREWS IN THE INTERIOR ENDPLATE OF C6 LEVEL AND SUPERIOR ENDPLATE OF C7 LEVEL FRACTURED AT THE PROXIMAL THREADED PORTION.

  Patient problems: Failure of Implant

  MAUDE report 7051329 ↗
• MalfunctionSep 29, 2016Fracture; Fracture

  ON (B)(6) 2016, A PATIENT UNDERWENT A TWO-LEVEL (C5-C6 AND C6-C7) ACDF WITH PEEK IMPLANTS AND INTEGRAL SCREWS DIRECTED CRANIALLY AND CAUDALLY AT EACH IMPLANT. FOUR MONTHS POSTOPERATIVE, THE PATIENT REPORTED EXPERIENCING SOME PAIN. RADIOGRAPHS WERE PERFORMED AND NOTED THE CRANIALLY DIRECTED SCREW AT C5-C6 BROKE APPROXIMATELY MIDWAY ALONG THE SHANK. REVISION SURGERY HAS NOT OCCURRED.

  Patient problems: Pain

  MAUDE report 5988533 ↗