PEEK PREVAIL™ Cervical Interbody Device 4210564Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00613994502087), received between Nov 23, 2016 and Sep 26, 2023 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2023Break; Device Handling Problem; Break; Device Handling Problem

  INFORMATION WAS RECEIVED FROM A (REGULATORY BODY, PATIENT, HEALTH CARE PROFESSIONAL) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH INTERBODY DEVICE. IT WAS REPORTED THAT MEDTRONIC PEEK PREVAIL THE TOP SCREW RETENTION WIRE BROKE INTO PIECES. IT WAS NOTICED ON X-RAYS BY NEUROSURGERY BUT DIDN'T HAVE PLANS TO REMOVE/REPLACE THE DEVICE. IN TIME BETWEEN 2018 AND 2022, THE TOP SCREW RETENTION WIRE BROKE INTO 3 PIECES. THE MANUFACTURER'S INSTRUCTIONS FOR IMPLANTING THE DEVICE WERE NOT FOLLOWED. THE DEVICE WAS NOT IMPLANTED FLUSH WITH TOP AND BOTTOM VERTEBRAE AS PER MANUFACTURERS SURGICAL TECHNIQUE MANUAL. NO COBB ANGLE WAS USED(RADIOLOGY). IT APPEARS THAT SCREWS LONGER THAN DISC SPACE WERE USED. RADIOLOGY REPORT ON 2013 SAID SCREWS WERE VERY PROUD, LOTS OF AIR WAS STILL IN NECK, AND RECOMMENDED RAD GRAFTS TO CHECK ALIGNMENT BUT IT WAS NOT DONE. SINCE THE 2013 ACDF PROCEDURE, PATIENT HAD SUFFERED WITH SEVERE THROAT, EAR, MOUTH, NECK PAIN, AND DIFFICULTY SWALLOWING. PATIENT HAD NUMEROUS FALLS, ONE SERIOUS ONE IN 2020 IN WHICH LEG WAS BROKEN. IT IS POSSIBLE THE WIRE BROKE DURING THAT FALL AS PATIENT ALSO HIT THE HEAD. IT ALSO MAY HAVE BROKEN IN 2021 WHERE PATIENT

  Patient problems: Bone Fracture(s); Dysphagia/ Odynophagia; Fall; Neck Pain; Nervous System Injury; Pain

  MAUDE report 17819707 ↗
• MalfunctionJun 23, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS RADICULAR FOR ACDF THERAPY (LEVELS IMPLANTED WERE C4-C5-C6). IT WAS REPORTED THAT THE CAGE BROKE WHILE INSERTION, HAD TO EXPLANTED AND WAS REPLACED WITH ALTERNATE CAGE. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12047146 ↗
• MalfunctionFeb 2, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT SPINAL THERAPY FOR CERVICAL DDD. IT WAS REPORTED THAT THE IMPLANT WAS BROKEN DURING PROCEDURE. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. THE IMPLANTATION AND EXPLANATION WAS COMPLETED ON SAME DAY. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11270807 ↗
• MalfunctionOct 14, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL (HCP) VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH CERVICAL RADICUL OPATHY SUGGESTED FOR SPINAL THERAPY. PROCEDURE USED WAS ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). LEVELS IMPLANTED C6-7. EVENT OCCURRED INTRA-OP. IT WAS REPORTED THAT DURING THE IMPLANTATION, SURGEON FIRST CHECKED WITH THE TRIAL AND THEN APPROPRIATE SIZE OF IMPLANT WAS OPEN. AFTER HOLDING THE IMPLANT WITH THE HOLDER, SURGEON USED THE MALLET TO SETTLE DOWN THE IMPLANT IN THE SPACE CREATED. WHEN THE HOLDER WAS GETTING DISENGAGED/ RELEASED THE FIRST HALF CAME OUT WITH THE HOLDER THE REST WAS HALF INSIDE THE BODY AND LATER IT WAS REMOVED COMPLETELY FROM THE PATIENT AND THEN NEW IMPLANT WAS USED AS A REPLACEMENT. BREAK AS REPORTED. NO FRAGMENTS LEFT IN PATIENT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WAS REPORTED. DEVICE RETURN STATUS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10676202 ↗
• InjuryDec 9, 2019Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT FUSION AND FIXATION AT C3-C4 DUE TO DEGENERATION AND MYELOPATHY. THE ALLEGED DEVICE WAS IMPLANTED DURING THIS SURGERY. ON AN UNKNOWN DATE, POST-OP, THE SCREW SLIPPED OUT OF THE IMPLANT AFTER BREAKING THE LOCKING WIRE AND GOT STUCK IN THE ESOPHAGUS. ALLEGEDLY, THIS LED TO PAIN AND SWALLOWING ISSUES. HENCE, ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY. THE BROKEN WIRE WAS RECOVERED BUT THE SCREW COULD NOT BE RECOVERED. IT WAS FOUND THAT THE SCREW WAS HIDDEN INSIDE THE ESOPHAGUS AND OPENING THE ESOPHAGUS WAS MORE RISKY. THE SCREW CAN STILL BE SEEN ON X-RAY. PATIENT IS RECOVERING WITH THE SCREW IN HIS THROAT WITH CONTINUED PROBLEMS BUT MINIMAL PAIN.

  Patient problems: Dysphagia/ Odynophagia; Injury; Pain

  MAUDE report 9438507 ↗
• InjurySep 19, 2019Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION DUE TO MYELOPATHY. ON AN UNKNOWN DATE, POST-OP, THE SCREW OF THE REPORTED PRODUCT BACKED-OUT FROM THE CONSTRUCT. THE BACKED-OUT SCREW PERFORATED THE ESOPHAGUS AND CAUSED PAIN TO THE PATIENT. THE STRING THAT HOLDS IN THE SCREW WAS ALSO BROKEN. HENCE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019, WHEREIN THE IMPLANT WAS REMOVED AND WAS REPLACED BY WITH PLATES. PATIENT WAS REPORTED TO BE SUFFERING WITH INJURY EVEN AFTER THE REVISION SURGERY.

  Patient problems: Injury; Pain; Perforation of Esophagus

  MAUDE report 9086266 ↗
• MalfunctionJun 20, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGERY AT C3-4 DUE TO CERVICAL BILATERAL RADICULOPATHY. INTRA-OP, THE IMPLANT WAS FOUND BROKEN IN TWO PARTS AFTER THE PRODUCT INSERTION WHILE USING HAMMER TO FIX IT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8715112 ↗
• MalfunctionDec 7, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH CERVICAL DEGENERATIVE DISEASE/ SPINAL STENOSIS AND UNDERWENT ANTERIOR CERVICAL DECOMPRESSION. DURING THE SURGERY, A FRACTURE OCCURRED DURING THE PARTIAL IMPLANTATION OF PEEK. THE DIRECTOR USED A PAIR OF PLIERS TO CLAMP IT OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8144587 ↗
• MalfunctionOct 18, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH CERVICAL CANAL STENOSIS AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE. DURING THE SURGERY, THE IMPLANT WAS DAMAGED WHILE TIGHTENING THE SCREW AND WAS FOUND BROKEN. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE BROKEN PART REMAINED IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7982347 ↗
• MalfunctionSep 11, 2018Break; Break

  TYPE OF PROCEDURE OR TECHNIQUE USED: ANTERIOR CERVICAL DISCECTOMY PRE-OPERATIVE DIAGNOSIS: CERVICAL SPINE INSTABILITY IT WAS REPORTED THAT INTRA-OP, IMPLANT BROKE DURING THE IMPLANTATION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED IN THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7865839 ↗
• MalfunctionDec 18, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CERVICAL SPINE FUSION SURGERY. INTRA OPERATIVELY, THE CAGE WAS BROKEN. THE DEVICE CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7125081 ↗
• MalfunctionOct 16, 2017Break; Break

  IT WAS REPORTED THAT DURING A SPINAL SURGERY, THE PRODUCT BROKE. NO FRAGMENTS OF THE PRODUCT REMAINED INSIDE THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6950681 ↗
• MalfunctionAug 24, 2017Crack; Crack

  PROCEDURE USED: ANTERIOR CERVICAL DISCECTOMY WITH FUSION (ACDF) LEVELS OPERATED: C6-C7 IT WAS REPORTED THAT DURING SURGERY, WHILE REMOVING THE C6 SCREW A PORTION OF THE IMPLANT CRACKED. THE IMPLANT WAS REATTACHED WITH INSERTER FOR REMOVAL, BUT IT WAS DIFFICULT TO BE PULLED OUT. FINALLY THE IMPLANT WAS REPLACED. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6816124 ↗
• MalfunctionJul 5, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION AT LEVELS C3-C4 AND C4-C5. ON (B)(6) 2017, ONE MONTH AFTER THE SURGERY, X-RAYS REVEALED THAT THE NITINOL WIRE IN THE DEVICE WHICH WORKS AS A LOCKING MECHANISM IN RESTRICTING SCREW PULL OUT, WAS FOUND TO BE BROKEN FROM ONE END. NO PATIENT COMPLICATIONS WERE REPORTED .

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6685555 ↗
• MalfunctionJul 5, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION AT LEVELS C3-C4 AND C4-C5. ON (B)(6) 2017, ONE MONTH AFTER THE SURGERY, X-RAYS REVEALED THAT THE NITINOL WIRE IN THE DEVICE WHICH WORKS AS A LOCKING MECHANISM IN RESTRICTING SCREW PULL OUT, WAS FOUND TO BE BROKEN FROM ONE END. NO PATIENT COMPLICATIONS WERE REPORTED .

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6685553 ↗
• MalfunctionMay 23, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT PATIENT WITH DEGENERATIVE DISC DISEASE UNDERWENT FUSION AT C5-C6, INTRA-OP, SCREW WENT OFF THROUGH THE IMPLANT SCREW HOLE. THE SCREW COULD NOT ENGAGE THE LOWER HOLE AS THE SCREW HEAD WENT PAST COMPLETELY THE LOWER HOLE WITHOUT BREAKING / VIOLATING THE HOLE AS A RESULT DOCTOR HAD USE AND PLATE AND SCREW AS A RESCUE MEASUREMENT. PRODUCT CAME IN CONTACT WITH PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6583761 ↗
• MalfunctionDec 2, 2016Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT PRESENTED WITH PRE-OPERATIVE DIAGNOSIS: DEGENERATIVE DISK DISEASE OF CERVICAL SPINE. PATIENT HAD BOTH PAIN <(>&<)> SYMPTOMS OF NEUROLOGICAL DEFICIT. FOR WHICH PATIENT UNDERWENT ANTERIOR CERVICAL DISKECTOMY AND FUSION (ACDF). INTRA-OP, WHILE IMPLANTING, THE IMPLANT WAS IMPACTED AS PER STEPS OF SURGICAL TECHNIQUE FOR A SNUG FIT. SURGEON WAS NOT HAPPY WITH THE POSITIONING OF THE IMPLANT. IMPLANT WAS SLIGHTLY RETRACTED BACK <(>&<)> AGAIN IMPACTED ON. DURING THIS PROCEDURE THE POSTERIOR HALF OF THE IMPLANT BROKE. MORE THAN HALF OF THE 'I' OF 'I-BEAM' DESIGNED IMPLANT GOT SEPARATED FROM THE ANTERIOR ELEMENTS OF THE IMPLANT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6140447 ↗
• MalfunctionNov 23, 2016Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION DUE TO DEGENERATIVE DISC DISEASE AT LEVELS C6-7. INTRA-OP, CAGE BROKE. ANOTHER CAGE WAS INSERTED WITHOUT ANY ERROR. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6123598 ↗