Centerpiece Plate Fixation System 8532067Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000552206), received between May 6, 2024 and Apr 22, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C4-6 LAMINOPLASTY FOR C3-7 STENOSIS. IT WAS REPORTED THAT THE SCREW FRACTURED WHILE HALF WAY INSERTED.. A PORTION OF THE SCREW WAS EXPLANTED, THE OTHER PIECE STILL REMAINS IN PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. NO HOSPITALIZATION/PROLONGATION OF EXISTING HOSPITALIZATION WAS NECESSARY AND NO ADDITIONAL/REVISION SURGERY PERFORMED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21879565 ↗
• MalfunctionApr 22, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C4-6 LAMINOPLASTY FOR C3-7 STENOSIS. IT WAS REPORTED THAT THE SCREW FRACTURED WHILE HALF WAY INSERTED. A PORTION OF THE SCREW WAS EXPLANTED, THE OTHER PIECE STILL REMAINS IN PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. NO HOSPITALIZATION/PROLONGATION OF EXISTING HOSPITALIZATION WAS NECESSARY AND NO ADDITIONAL/REVISION SURGERY PERFORMED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21879528 ↗
• MalfunctionMar 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LAMINOPLASTY (L EVELS IMPLANTED C3-C7) DUE TO UNKNOWN INDICATION. IT WAS REPORTED THAT 2.0 X 7 MM CENTERPIECE 2.0 X2 SCREWS BROKE IN HALF RIGHT UNDER THE POST HEAD OF THE CENTERPIECE 2.0 SCREW DURING IMPLANTING. THE SURGEON DRILLED WITH THE 1.3 X 7 MM DRILL THEN PLACED THE SCREW IMMEDIATELY FOLLOWING HE MENTION THE BONE WAS A LITTLE HARD HOWEVER THEY SNAPPED OFF PRETTY EASY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21696169 ↗
• MalfunctionFeb 10, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C4-6 LAMINOPLASTY FOR C3-7 STENOSIS. IT WAS REPORTED THAT THE SCREW FRACTURED WHILE HALFWAY INSERTED. A PORTION OF THE SCREW WAS EXPLANTED, THE OTHER PIECE STILL REMAINS IN PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. NO HOSPITALIZATION/PROLONGATION OF EXISTING HOSPITALIZATION WAS NECESSARY AND NO ADDITIONAL/REVISION SURGERY PERFORMED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21341425 ↗
• MalfunctionJan 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A BONE SCREW USED IN LAMINOPLASTY THERAPY FOR NECK PAIN. LEVELS IMPLANTED: C3-C7 IT WAS REPORTED THAT PER THE HEALTHCARE PROFESSIONAL, WHEN TAKING THE SCREWDRIVER OFF THE SCREW HEAD, HE BELIEVES THAT HE MAY HAVE TORQUED THE DRIVER AND SNAPPED THE HEAD OFF THE SCREW IN THE DRIVER. A FRAGMENT OF THE IMPLANT IS REMAINING IN THE PATIENT - A SCREW SHANK IN C4 LATERAL MASS. NO ADDITIONAL SURGERY WAS REQUIRED AND AN ATTEMPT TO REMOVE THE IMPLANT WAS UNSUCCESSFUL. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21236341 ↗
• MalfunctionJan 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING UNKNOWN SPINAL THERAPY. THE PROCEDURE OR TECHNIQUE PERFORMED WAS LAMINOPLASTY. IT WAS REPORTED THAT, THE SCREWS WERE BROKEN. THE SCREW SHAFT/SHANK WAS LEFT IMPLANTED. THE SCREW SHAFT BROKE JUST BELOW THE DEPTH STOP/WASHER PART OF THE SCREW. THE PEG THAT SITS PROUD BROKE OFF IN THE DRIVER. THERE WAS NO REVISION SURGERY AS THE SURGEON DETERMINED THE SCREW SHAFT WAS IRRETRIEVABLE AND STATED THAT IT WOULD BE LEFT IMPLANTED. THE TWO SCREWS DID BREAK IN THE SAME WAY, HOWEVER THE SURGICAL TEAM THREW AWAY THE SECOND BROKEN SCREW PIECE AND IT WAS UN-RETRIEVABLE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21187813 ↗
• MalfunctionJan 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING UNKNOWN SPINAL THERAPY. THE PROCEDURE OR TECHNIQUE PERFORMED WAS LAMINOPLASTY. IT WAS REPORTED THAT, THE SCREWS WERE BROKEN. THE SCREW SHAFT/SHANK WAS LEFT IMPLANTED. THE SCREW SHAFT BROKE JUST BELOW THE DEPTH STOP/WASHER PART OF THE SCREW. THE PEG THAT SITS PROUD BROKE OFF IN THE DRIVER. THERE WAS NO REVISION SURGERY AS THE SURGEON DETERMINED THE SCREW SHAFT WAS IRRETRIEVABLE AND STATED THAT IT WOULD BE LEFT IMPLANTED. THE TWO SCREWS DID BREAK IN THE SAME WAY, HOWEVER THE SURGICAL TEAM THREW AWAY THE SECOND BROKEN SCREW PIECE AND IT WAS UN-RETRIEVABLE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21187811 ↗
• MalfunctionJan 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LAMINOPLASTY (L EVELS IMPLANTED C3-C7) DUE TO UNKNOWN INDICATION. IT WAS REPORTED THAT 2.0 X 7 MM CENTERPIECE 2.0 X2 SCREWS BROKE IN HALF RIGHT UNDER THE POST HEAD OF THE CENTERPIECE 2.0 SCREW DURING IMPLANTING. THE SURGEON DRILLED WITH THE 1.3 X 7 MM DRILL THEN PLACED THE SCREW IMMEDIATELY FOLLOWING HE MENTION THE BONE WAS A LITTLE HARD HOWEVER THEY SNAPPED OFF PRETTY EASY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21186424 ↗
• MalfunctionMay 23, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING CERVICAL LAMINO PLASTY THERAPY FOR CERVICAL STENOSIS. LEVELS IMPLANTED WAS C5-C6. IT WAS REPORTED THAT THE SCREW WAS BROKEN AND THREAD OF SCREW STILL ON PATIENT .  THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19383729 ↗
• MalfunctionMay 8, 2024Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LAMINOPLASTY AT C4-6 FOR CERVICAL STENOSIS. IT WAS REPORTED THAT THE SCREW HEAD SHEARED OFF. THE BOTTOM PART OF SCREW REMAINS IN THE BONE. THE SURGEON USED A DIFFERENT DRILL THAN THE DISPOSABLE CENTERPIECE DRILL TO MAKE PILOT HOLES. THEN PLACED THE SCREW WHEN IT SHEARED OFF. NO ADDITIONAL/REVISION SURGERY PERFORMED TO RETRIEVE THE FRAGMENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19266325 ↗
• MalfunctionMay 6, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE LAMINPLASTY AT C3-5 LEVELS. IT WAS REPORTED THAT THE SURGEON WAS SCREWING IN A CENTERPIECE SCREW. WITH THE SCREW HALF WAY INSERTED IT SUDDENLY BROKE IN HALF, HALF IN THE PATIENT AND THE REMAINING HALF WAS STUCK INSIDE THE DRIVER. THE SURGEON WAS ABLE TO USE A NEEDLE DRIVER AND UNTHREAD THE SCREW OUT OF THE PATIENT.NO FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT THIS WAS A C3-5 LAMINOPLASTY PROCEDURE FOR UNILATERAL STENOSIS ON THE RIGHT SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19245984 ↗