Centerpiece Plate Fixation System 8532065Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000552190), received between Nov 6, 2024 and Apr 23, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING BONE SCREWS USED IN LAMINOPLASTY C3-7 THERAPY FOR CERVICAL STENOSIS. IT WAS REPORTED THAT THE THREADED PORTION OF THE SCREW BROKE OFF IN THE CORRESPONDING LEVELS AND ANATOMY - ONE AT C6 LAMINA AND TWO AT C7 LATERAL MASS. FRAGMENT OF THE IMPLANT WAS REMAINING IN THE PATIENT. NO ADDITIONAL SURGERY WAS PERFORMED. NO PATIENT SYMPTOMS WERE REPORTED. PATIENT'S MEDICAL HISTORY INCLUDES ALLERGIES TO IODINE, IV CONTRAST. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21887617 ↗
• MalfunctionApr 22, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING BONE SCREWS USED IN LAMINOPLASTY C3-7 THERAPY FOR CERVICAL STENOSIS. IT WAS REPORTED THAT THE THREADED PORTION OF THE SCREW BROKE OFF IN THE CORRESPONDING LEVELS AND ANATOMY - ONE AT C6 LAMINA AND TWO AT C7 LATERAL MASS. FRAGMENT OF THE IMPLANT WAS REMAINING IN THE PATIENT. NO ADDITIONAL SURGERY WAS PERFORMED. NO PATIENT SYMPTOMS WERE REPORTED. PATIENT'S MEDICAL HISTORY INCLUDES ALLERGIES TO IODINE, IV CONTRAST. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21883158 ↗
• MalfunctionApr 22, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A BONE SCREW USED IN LAMINOPLASTY WITH CENTERPIECE 2.0. NORMAL TECHNIQUE FOR STENOSIS. IT WAS REPORTED THE THREE CENTERPIECE SCREWS BROKE AND ONE OF WHICH HCP WAS UNABLE TO RETRIEVE AND THEREFORE THE REMAINDER OF THE SCREW WAS LEFT IN THE PATIENT. LEVELS IMPLANTED WAS C4-C6. THERE WAS NO ADDITIONAL SURGERY NEEDED FROM THIS EVENT, AND THERE IS NO PLAN TO REMOVE THE BROKEN SCREW LEFT INSIDE THE PATIENT. THE PROCEDURE WAS DONE SUCCESSFULLY. BUT THERE WAS A SMALL DELAY IN THE PROCEDURE WHEN TRYING TO RETRIEVE ONE OF THE SCREWS. THIS DELAY MIGHT HAVE LASTED FOR APPROXIMATELY 20 SECONDS. NO ADVERSE EVENT OCCURRED TO PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21880919 ↗
• MalfunctionApr 22, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A BONE SCREW USED IN LAMINOPLASTY WITH CENTERPIECE 2.0. NORMAL TECHNIQUE FOR STENOSIS. IT WAS REPORTED THE THREE CENTERPIECE SCREWS BROKE AND ONE OF WHICH HCP WAS UNABLE TO RETRIEVE AND THEREFORE THE REMAINDER OF THE SCREW WAS LEFT IN THE PATIENT. LEVELS IMPLANTED WAS C4-C6. THERE WAS NO ADDITIONAL SURGERY NEEDED FROM THIS EVENT, AND THERE IS NO PLAN TO REMOVE THE BROKEN SCREW LEFT INSIDE THE PATIENT. THE PROCEDURE WAS DONE SUCCESSFULLY. BUT THERE WAS A SMALL DELAY IN THE PROCEDURE WHEN TRYING TO RETRIEVE ONE OF THE SCREWS. THIS DELAY MIGHT HAVE LASTED FOR APPROXIMATELY 20 SECONDS. NO ADVERSE EVENT OCCURRED TO PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21880890 ↗
• MalfunctionApr 22, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING SCREWS USED IN LAMINOPLASTY THERAPY. LEVELS IMPLANTED: 2. IT WAS REPORTED THAT THE SURGEON HAD FOLLOWED THE STEPS IN THE CENTERPIECE 2.0 SURGICAL TECHNIQUE BUT IT STILL RESULTED IN THE BREAKING OF 2 SCREWS DURING IMPLANTING. THE SCREWS HAVE BEEN EXPLANTED PARTIALLY AS THE SCREWS BROKE OFF AT NECK. THE SCREW THREADS ARE REMAINING IN THE PATIENT. PATIENT SYMPTOMS ARE UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21879361 ↗
• MalfunctionJan 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING SCREWS USED IN LAMINOPLASTY THERAPY. LEVELS IMPLANTED: 2 IT WAS REPORTED THAT THE SURGEON HAD FOLLOWED THE STEPS IN THE CENTERPIECE 2.0 SURGICAL TECHNIQUE BUT IT STILL RESULTED IN THE BREAKING OF 2 SCREWS DURING IMPLANTING. THE SCREWS HAVE BEEN EXPLANTED PARTIALLY AS THE SCREWS BROKE OFF AT NECK. THE SCREW THREADS ARE REMAINING IN THE PATIENT. PATIENT SYMPTOMS ARE UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21236316 ↗
• MalfunctionJan 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A BONE SCREW USED IN LAMINOPLASTY WITH CENTERPIECE 2.0. NORMAL TECHNIQUE FOR STENOSIS. IT WAS REPORTED THE THREE CENTERPIECE SCREWS BROKE AND ONE OF WHICH HCP WAS UNABLE TO RETRIEVE AND THEREFORE THE REMAINDER OF THE SCREW WAS LEFT IN THE PATIENT. LEVELS IMPLANTED WAS C4-C6. THERE WAS NO ADDITIONAL SURGERY NEEDED FROM THIS EVENT, AND THERE IS NO PLAN TO REMOVE THE BROKEN SCREW LEFT INSIDE THE PATIENT. THE PROCEDURE WAS DONE SUCCESSFULLY. BUT THERE WAS A SMALL DELAY IN THE PROCEDURE WHEN TRYING TO RETRIEVE ONE OF THE SCREWS. THIS DELAY MIGHT HAVE LASTED FOR APPROXIMATELY 20 SECONDS. NO ADVERSE EVENT OCCURRED TO PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21215665 ↗
• MalfunctionJan 20, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING BONE SCREWS USED IN LAMINOPLASTY C3-7 THERAPY FOR CERVICAL STENOSIS. IT WAS REPORTED THAT THE THREADED PORTION OF THE SCREW BROKE OFF IN THE CORRESPONDING LEVELS AND ANATOMY - ONE AT C6 LAMINA AND TWO AT C7 LATERAL MASS. FRAGMENT OF THE IMPLANT WAS REMAINING IN THE PATIENT. NO ADDITIONAL SURGERY WAS PERFORMED. NO PATIENT SYMPTOMS WERE REPORTED. PATIENT'S MEDICAL HISTORY INCLUDES ALLERGIES TO IODINE, IV CONTRAST. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21193133 ↗
• MalfunctionJan 20, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPINAL DEVICE USED IN C3-6 LAMINOPLASTY. IT WAS REPORTED THAT THE SHANK OF CENTERPIECE SCREW SHEARED OFF WHILE IMPLANTING. THE IMPLANTED TIP OF THE SCREW WAS LEFT IN THE PATIENT. A NEW HOLE WAS DRILLED AND NEW SCREW WAS IMPLANTED JUST ADJACENT TO THE SHEARED SCREW. THE PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE IS C3-6 LAMINOPLASTY. THERE WERE NO OTHER SYMPTOMS ADVERSE REACTIONS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WAS NO PLATE MALFUNCTION. IT WAS SAID THAT NO REVISION NEEDED. THE BROKEN FRAGMENT IS NOT AVAILABLE, THE HOSPITAL DISPOSED OF IT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21190906 ↗
• MalfunctionJan 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LAMINOPLASTY FOR CERVICAL STENOSIS. IT WAS REPORTED THAT, A 5MM SCREW WAS PLACED AND THE TOP SNAPPED OFF WAS LEFT IN PATIENT WITH NO DIFFICULTIES. THE LEVELS IMPLANTED WERE C4-C6. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT, NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21187844 ↗
• MalfunctionJan 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SCREW USED IN CERVICAL LAMINOPLASTY FOR CERVICAL MYELOPATHY. IT WAS REPORTED THAT THE SURGEON HAD IMPLANTED SCREW THROUGH CENTERPIECE PLATE AND THE HEAD ENDED UP SNAPPING OFF. IT IS POSSIBLE THAT THE AMOUNT OF TORQUE HE WAS APPLYING WAS TOO MUCH FOR THE SCREW AND IT BROKE. A FRAGMENT OF THE IMPLANT OR INSTRUMENT IS REMAINING IN THE PATIENT - THE SHAFT OF THE SCREW (5MM) IS STILL IN BONE. NO NEGATIVE EFFECT TO THE PATIENT. NO PATIENT SYMPTOMS WERE REPORTED. NO ADDITIONAL SURGERY OR TREATMENT WAS NEEDED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21186579 ↗
• MalfunctionJan 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING CERVICAL LAMINO PLASTY FOR MYELOPATHY. IT WAS REPORTED THAT HEAD OF SCREW SHEERED OFF. PORTION OF THE SCREW SHANK INCLUDING THEADS REMAINED IN PATIENT. SURGEON JUST REPOSITIONED PLATE AND SECURED AT THE SAME LEVEL THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21186552 ↗
• MalfunctionNov 6, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING CERVICAL LA MINOPLASTY FOR CERVICAL STENOSIS. THE LEVELS IMPLANTED ARE C4,C5,C6. IT WAS REPORTED THAT THE SCREW SHEARED DURING INSERTION. THE THREADED PORTION ON CREW REMAINS IN LATERAL MASS AT C5. THE SURGEON DID NOT WANT TO REMOVE THE REMNANT AS IT WOULD HAVE RESULTED IN ADDITIONAL BONE LOSS. SURGEON ALSO FELT THE REMNANT WOULD NOT MIGRATE AS SCAR/BONE WOULD HEAL OVER IT. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20620328 ↗